SELF MIXING CROWN LOK

GUDID 00840479200644

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive
Primary Device ID00840479200644
NIH Device Record Keyc0b325eb-0a2f-43e6-8fdd-640f9894fff9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSELF MIXING CROWN LOK
Version Model Number1SMCLB
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
GS100840479200644 [Primary]
HIBCCD7981SMCLB0 [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 Date2026-03-03
Device Publish Date2026-02-23

Devices Manufactured by RELIANCE ORTHODONTIC PRODUCTS INC

00840479200040 - CHEEK RETRACTOR2026-03-03
00840479200057 - CHEEK RETRACTOR2026-03-03
00840479200507 - RELY A BOND2026-03-03
00840479200514 - RELY A BOND2026-03-03
00840479200521 - RENEW SYSTEM POINTS2026-03-03
00840479200538 - RENEW SYSTEM POINTS2026-03-03
00840479200545 - RENEW SYSTEM POINTS2026-03-03
00840479200552 - RELIAWAX2026-03-03

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