Calibra® Veneer Esthetic Resin Cement 607306

GUDID D0026073060

Calibra® Veneer Try-In Paste Syringe Refill Package - Bleach Shade

DENTSPLY INTERNATIONAL INC.

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• Primary Device ID: D0026073060
• NIH Device Record Key: ab1f3e6b-b65b-46cf-be2b-39e02936dc26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibra® Veneer Esthetic Resin Cement
• Version Model Number: 607306
• Catalog Number: 607306
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 2
• DM Exempt: true
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Store in a well ventilated place. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026073060 [Unit of Use]
HIBCC	D0026073061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040906

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: 2022-04-27
• Device Publish Date: 2022-04-19

On-Brand Devices [Calibra® Veneer Esthetic Resin Cement]

• D0026075001: Calibra® Veneer Kit
• D0026073060: Calibra® Veneer Try-In Paste Syringe Refill Package - Bleach Shade
• D0026072061: Calibra® Veneer Syringe Refill Package - Bleach Shade