Calibra® Bio Bioceramic Luting Cement 607604

GUDID D0026076040

Calibra® Bio 14 Capsules Refill

DENTSPLY INTERNATIONAL INC.

Glass ionomer dental cement

• Primary Device ID: D0026076040
• NIH Device Record Key: c3a3fb91-c825-43ed-b082-9dd24161f810
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibra® Bio Bioceramic Luting Cement
• Version Model Number: 607607
• Catalog Number: 607604
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 14
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.
• Storage Environment Temperature: Between 4 Degrees Celsius and 39 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight. Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026076040 [Unit of Use]
HIBCC	D0026076041 [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: 2022-04-28
• Device Publish Date: 2022-04-20

On-Brand Devices [Calibra® Bio Bioceramic Luting Cement]

• D0026076091: Calibra® Bio Powder/Liquid Refill
• D0026076070: Calibra® Bio 30 Capsules Refill
• D0026076040: Calibra® Bio 14 Capsules Refill
• D0026076011: Calibra® Bio Capsules Introductory Kit
• D0026076080: Calibra® Bio Capsule Sample