MASTER-DENT

Basic Information

• Brand Name: MASTER-DENT
• Primary DI: 00816526023573
• Version / Model: 10-000-KY
• Catalog Number: 10-000-KY
• Company Name: DENTONICS INC
• Labeler DUNS: 186285342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-11
• Public Version: 1
• Public Version Date: 2021-06-21
• Public Version Status: New
• Public Device Record Key: 9254de78-9a75-43f0-bac7-62e9cb7fdeba

Device Description

Zinc Phosphate Cement, 32gm Powder, 17.5ml Liquid (Yellow)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
16710	Zinc phosphate dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid. It typically includes some additional fillers/components. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816526023573	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]