COPALITE

GUDID 00850015110306

DENTAL VARNISH AND TUBULI SEAL

TEMREX CORPORATION

Dental restorative material varnish
Primary Device ID00850015110306
NIH Device Record Keyc234725e-bf93-443d-a983-77b8327ddd4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOPALITE
Version Model Number4003
Company DUNS012072823
Company NameTEMREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015110306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVarnish, Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-03
Device Publish Date2020-02-24

On-Brand Devices [COPALITE]

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

Trademark Results [COPALITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COPALITE
COPALITE
73435064 not registered Dead/Abandoned
COOLEY & COOLEY, LTD.
1983-07-18
COPALITE
COPALITE
72148956 0749471 Live/Registered
COOLEY, JR.; RALPH C. HEIRS OF RALPH C.COOLEY, DECEASED
1962-07-13

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