Calibra® Bio Bioceramic Luting Cement 607608

GUDID D0026076080

Calibra® Bio Capsule Sample

DENTSPLY INTERNATIONAL INC.

Dental composite resin

• Primary Device ID: D0026076080
• NIH Device Record Key: 74c72dab-94e6-4b63-bbe0-074ae2127393
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibra® Bio Bioceramic Luting Cement
• Version Model Number: 607608
• Catalog Number: 607608
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store in sealed packs at temperatures between 4° and 20° C.
• Special Storage Condition, Specify: Between 0 and 0 *Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not open the aluminum pouch until immediately before use.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026076080 [Unit of Use]
HIBCC	D0026076081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113040

FDA Product Code

• EMA: CEMENT, DENTAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-28
• Device Publish Date: 2022-09-20

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