Calibra® Bio 607600

GUDID D0026076000

Calibra® Bio Evaluator Kit

DENTSPLY INTERNATIONAL INC.

Glass ionomer dental cement

• Primary Device ID: D0026076000
• NIH Device Record Key: e2aad992-ef3d-49db-825f-bad9700cc638
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibra® Bio
• Version Model Number: 607600
• Catalog Number: 607600
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 5
• 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

• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.
• Storage Environment Temperature: Between 4 Degrees Celsius and 20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026076000 [Unit of Use]
HIBCC	D0026076001 [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: 2022-09-01
• Device Publish Date: 2022-08-24

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