COPALITE

GUDID 00850015110283

DENTAL VARNISH AND TUBULI SEAL

TEMREX CORPORATION

Dental restorative material varnish

• Primary Device ID: 00850015110283
• NIH Device Record Key: 65c2b692-8294-4685-8596-cd4bb84153e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COPALITE
• Version Model Number: 4001
• Company DUNS: 012072823
• Company Name: TEMREX CORPORATION
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015110283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851030

FDA Product Code

• LBH: Varnish, Cavity

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: 2020-03-03
• Device Publish Date: 2020-02-24

On-Brand Devices [COPALITE]

• 00850015110306: DENTAL VARNISH AND TUBULI SEAL
• 00850015110283: DENTAL VARNISH AND TUBULI SEAL
• 00850015110290: DENTAL VARNISH AND TUBULI SEAL