COPALITE

Basic Information

• Brand Name: COPALITE
• Primary DI: 00850015110306
• Version / Model: 4003
• Company Name: TEMREX CORPORATION
• Labeler DUNS: 012072823
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-24
• Public Version: 1
• Public Version Date: 2020-03-03
• Public Version Status: New
• Public Device Record Key: c234725e-bf93-443d-a983-77b8327ddd4f

Device Description

DENTAL VARNISH AND TUBULI SEAL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBH	Varnish, Cavity	Dental	872.3260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45294	Dental restorative material varnish	A liquid substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration (especially when a dental silicate or glass ionomer cement is used as a filling material). The device typically consists of dissolved artificial resins. 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	00850015110306	GS1

Premarket Submissions

Submission Number	Supplement Number
K851030	000