CROWN LOK

GUDID 00840479201139

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive
Primary Device ID00840479201139
NIH Device Record Key31e835be-44b3-4ea7-8285-e9f1bd21007f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCROWN LOK
Version Model NumberCLSAB
Company DUNS113170088
Company NameRELIANCE ORTHODONTIC PRODUCTS INC
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
GS100840479201139 [Primary]
HIBCCD798CLSAB0 [Previous]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-02
Device Publish Date2026-02-20

On-Brand Devices [CROWN LOK]

D798SMCLBK0Crown Lok is intended for use as a cement for metal crowns and orthodontic bands. This is the S
D798SMCLB0Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. This is th
D7981SMCLB0Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. This is th
00840479201139CLSAB

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