TheraCem D-46311

GUDID D757D463110

Theracem 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

• Primary Device ID: D757D463110
• NIH Device Record Key: 4af013cb-570d-4a33-ab58-238b2c1f02b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraCem
• Version Model Number: D-46311
• Catalog Number: D-46311
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757D463110 [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: 4
• Public Version Date: 2022-05-18
• Device Publish Date: 2017-09-01

On-Brand Devices [TheraCem]

• D757D46302S0: TheraCem 1g Dual Syr. Sample
• D757D46302PS0: TheraCem 1g Dual Syr. Sample Pkg
• D757D463110: Theracem 8g Dual Syringe
• 00810111541275: Theracem Refill Package
• 00810111541268: Theracem 8g Dual Syringe
• 00810111541282: TheraCem 1g Dual Syr. Sample
• 00810111541299: TheraCem 1g Dual Syr. Sample Pkg