Calibra® Esthetic Resin Cement 607056

GUDID D0026070561

Calibra® Esthetic Resin Cement Sampler

DENTSPLY INTERNATIONAL INC.

Dental composite resin

• Primary Device ID: D0026070561
• NIH Device Record Key: 2abad42d-a2fb-40ca-9085-db9135b6f357
• Commercial Distribution Discontinuation: 2019-10-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Calibra® Esthetic Resin Cement
• Version Model Number: 607056
• Catalog Number: 607056
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 1
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram
• Device Size Text, specify: 0
• Weight: 4.5 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026070561 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-10-03
• Device Publish Date: 2016-09-21

On-Brand Devices [Calibra® Esthetic Resin Cement]

• D0026070561: Calibra® Esthetic Resin Cement Sampler
• D0026070751: Calibra® Esthetic Resin Cement, Try-In Paste, Opaque, 2 (1.8g) syringe Refill Package
• D0026070741: Calibra® Esthetic Resin Cement, Try-In Paste, Translucent, 2 (1.8g) syringe Refill Package
• D0026070731: Calibra® Esthetic Resin Cement, Try-In Paste, Dark, 2 (1.8g) syringe Refill Package
• D0026070721: Calibra® Esthetic Resin Cement, Try-In Paste, Medium, 2 (1.8g) syringe Refill Package
• D0026070711: Calibra® Esthetic Resin Cement, Try-In Paste, Light, 2 (1.8g) syringe Refill Package