Z-Cem SA D-47021

GUDID 00810111542555

Z-Cem SA Translucent 6g Dual Syringe

BISCO INC.

Dental composite resin

• Primary Device ID: 00810111542555
• NIH Device Record Key: 3804b23c-cf34-47a7-aba9-c25d467cc7ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-Cem SA
• Version Model Number: D-47021
• Catalog Number: D-47021
• 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: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111542555 [Primary]
HIBCC	D757D470210 [Previous]

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: 2022-12-06
• Device Publish Date: 2022-11-28

On-Brand Devices [Z-Cem SA]

• D757D470210: Z-Cem SA Translucent 6g Dual Syringe
• 00810111542555: Z-Cem SA Translucent 6g Dual Syringe