TKO Clear

GUDID D798TKOC0

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive
Primary Device IDD798TKOC0
NIH Device Record Key55db7b3f-a6ae-4684-b5cb-dbdbbc8b35d4
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
HIBCCD798TKOC0 [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 Date2023-09-27
Device Publish Date2023-09-19

Devices Manufactured by RELIANCE ORTHODONTIC PRODUCTS INC

D79821BTIPS101 - Brush Tips2023-12-21
D798RBTA0 - Tweezers2023-12-21
D798RBTP0 - Tweezers2023-12-21
D798RBX0 - ReliaBox2023-12-21 ReliaBox
D798RBXK0 - ReliaBox2023-12-21 ReliaBox Kit
D7981BEGSSAM0 - Gel Etchant2023-09-27
D7981EGSSAM0 - Gel Etchant2023-09-27
D7981RWX0 - ReliaWax2023-09-27

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