Vatech Clismile

GUDID 08800018601105

This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material

Rayence Co., Ltd.

Orthodontic bracket, ceramic
Primary Device ID08800018601105
NIH Device Record Key2ca8e07f-e826-47e2-a19a-454359903bfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameVatech Clismile
Version Model Number01-1233
Company DUNS557804458
Company NameRayence Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800018601105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, Ceramic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-08
Device Publish Date2022-05-31

On-Brand Devices [Vatech Clismile ]

08800018601457This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601440This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601433This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601426This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601419This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601402This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601396This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601389This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601372This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601365This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601358This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601341This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601334This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601327This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601310This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601303This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601297This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601280This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601273This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601266This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601259This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601242This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601235This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601228This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601211This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601204This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601198This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601181This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601174This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601167This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601150This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601143This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601136This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601129This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601112This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601105This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601099This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601082This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601075This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601068This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601051This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601044This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601037This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601020This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601013This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018601006This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018600993This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018600986This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018600979This product is an orthodontic bracket and is used with orthodontic wire materials and other ort
08800018600962This product is an orthodontic bracket and is used with orthodontic wire materials and other or

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