TheraCem Ca D-46501

GUDID D757D465010

THERACEM Ca 8g DUAL SYRINGE

BISCO INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: D757D465010
• NIH Device Record Key: 3c2f72ed-c07f-4b6a-9f37-1d5b5476b63d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraCem Ca
• Version Model Number: D-46501
• Catalog Number: D-46501
• Company DUNS: 053529939
• Company Name: BISCO INC.
• Device Count: 1
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757D465010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161256

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: 3
• Public Version Date: 2022-05-18
• Device Publish Date: 2018-03-02

On-Brand Devices [TheraCem Ca]

• D757D46502S0: THERACEM Ca 1G DUAL SYR SAMPLE
• D757D46502PS0: THERACEM Ca 1g DUAL SYR SMPL PKG
• D757D465010: THERACEM Ca 8g DUAL SYRINGE
• 00810111541312: THERACEM Ca 8g REFILL PACKAGE
• 00810111541336: THERACEM Ca 1g DUAL SYR SMPL PKG
• 00810111541305: THERACEM Ca 8g DUAL SYRINGE