TKO Clear

GUDID D798TKOC150

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive
Primary Device IDD798TKOC150
NIH Device Record Key7bdfa038-4bfd-4e14-a317-ed43884d4f3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTKO Clear
Version Model NumberTKOC
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
HIBCCD798TKOC150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-08-09
Device Publish Date2024-08-01

On-Brand Devices [TKO Clear]

D798TKOC0TKOC
D798TKOC150TKOC
D7981TKOC150TKOC

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