Glaze

Basic Information

• Brand Name: Glaze
• Primary DI: D8370160100
• Version / Model: Kit - 16 oz - Special
• Catalog Number: 01-6010
• Company Name: Taub Products
• Labeler DUNS: 067488114
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 3
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: 7cac4856-079f-4a73-adfe-ba730a1a9dc9

Device Description

Glaze Kit contains a translucent acrylic and thinner that gives a gloss coating to provisional and permanent acrylic, and composite restorations. Glaze is quick setting and cures and bonds to all dental resins, including ethyl and methyl methacrylates, bis-acryl resins, polycarbonates, vinyl methacrylate copolymers, resin crowns and laminates, denture base, acrylic denture teeth and composite resins.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBD	Coating, Filling Material, Resin	Dental	872.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D8370160100	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	16	Fluid Ounce

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from open flame. See SDS.