Virage Ceramic Brackets 002-2004V

GUDID 00190746006647

COSMETIC VIRAGE UL LATERAL 018 T+10 A+8 R=0

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket, ceramic
Primary Device ID00190746006647
NIH Device Record Key8f3f25b9-7da5-4209-8cee-92b15e4c8bad
Commercial Distribution Discontinuation2017-02-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVirage Ceramic Brackets
Version Model Number002-2004V
Catalog Number002-2004V
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-7687
Emailinfo@americanortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746006647 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-24

On-Brand Devices [Virage Ceramic Brackets]

00190746007644COSMETIC VIRAGE UL LATERAL 022 T+14 A+8 R=0
00190746007637COSMETIC VIRAGE UR LATERAL 022 T+14 A+8 R=0
00190746007620COSMETIC VIRAGE UL CENTRAL 022 T+22 A+5 R=0
00190746007613COSMETIC VIRAGE UR CENTRAL 022 T+22 A+5 R=0
00190746007606COSMETIC VIRAGE LL 2ND BICUSPID 018 T-17 A=0 R=0 W/HK DIST
00190746007590COSMETIC VIRAGE LR 2ND BICUSPID 018 T-17 A=0 R=0 W/HK DIST
00190746007583COSMETIC VIRAGE MAND 2ND BICUSPID 018 T-17 A=0 R=0
00190746007576COSMETIC VIRAGE LL 1ST BICUSPID 018 T-11 A=0 R=0 W/HK DIST
00190746007569COSMETIC VIRAGE LR 1ST BICUSPID 018 T-11 A=0 R=0 W/HK DIST
00190746007552COSMETIC VIRAGE MAND 1ST BICUSPID 018 T-11 A=0 R=0
00190746007545COSMETIC VIRAGE LL CUSPID 018 T+7 A+5 R=0
00190746007538COSMETIC VIRAGE LL CUSPID 018 T+7 A+5 R=0 W/HK DIST
00190746007521COSMETIC VIRAGE LR CUSPID 018 T+7 A+5 R=0
00190746007514COSMETIC VIRAGE LR CUSPID 018 T+7 A+5 R=0 W/HK DIST
00190746007507COSMETIC VIRAGE MAND ANTERIOR 018 T=0 A=0 R=0
00190746007491COSMETIC VIRAGE UL BICUSPID 018 T-7 A=0 R=0 W/HK DIST
00190746007484COSMETIC VIRAGE UR BICUSPID 018 T-7 A=0 R=0 W/HK DIST
00190746007477COSMETIC VIRAGE MAX BICUSPID 018 T-7 A=0 R=0
00190746007460COSMETIC VIRAGE UL CUSPID 018 T+7 A+5 R=0
00190746007453COSMETIC VIRAGE UL CUSPID 018 T+7 A+5 R=0 W/HK DIST
00190746007446COSMETIC VIRAGE UR CUSPID 018 T+7 A+5 R=0
00190746007439COSMETIC VIRAGE UR CUSPID 018 T+7 A+5 R=0 W/HK DIST
00190746007422COSMETIC VIRAGE UL LATERAL 018 T+14 A+8 R=0
00190746007415COSMETIC VIRAGE UR LATERAL 018 T+14 A+8 R=0
00190746007408COSMETIC VIRAGE UL CENTRAL 018 T+22 A+5 R=0
00190746007392COSMETIC VIRAGE UR CENTRAL 018 T+22 A+5 R=0
00190746007385COSMETIC VIRAGE UL CUSPID 022 T-7 A+8 R=0
00190746007378COSMETIC VIRAGE UL CUSPID 022 T-7 A+8 R=0 W/HK DIST
00190746007361COSMETIC VIRAGE UR CUSPID 022 T-7 A+8 R=0
00190746007354COSMETIC VIRAGE UR CUSPID 022 T-7 A+8 R=0 W/HK DIST
00190746007347COSMETIC VIRAGE UL CUSPID 018 T-7 A+8 R=0
00190746007330COSMETIC VIRAGE UL CUSPID 018 T-7 A+8 R=0 W/HK DIST
00190746007323COSMETIC VIRAGE UR CUSPID 018 T-7 A+8 R=0
00190746007316COSMETIC VIRAGE UR CUSPID 018 T-7 A+8 R=0 W/HK DIST
00190746007309COSMETIC VIRAGE LL CUSPID 022 T-5 A+5 R5M W/HK DIST
00190746007293COSMETIC VIRAGE LR CUSPID 022 T-5 A+5 R5M W/HK DIST
00190746007286COSMETIC VIRAGE MAND ANTERIOR 022 T+3 A=0 R=0
00190746007279COSMETIC VIRAGE UL CUSPID 022 T+8 A+9 R5M W/HK DIST
00190746007262COSMETIC VIRAGE UR CUSPID 022 T+8 A+9 R5M W/HK DIST
00190746007255COSMETIC VIRAGE UL LATERAL 022 T+18 A+6 R=0
00190746007248COSMETIC VIRAGE UR LATERAL 022 T+18 A+6 R=0
00190746007231COSMETIC VIRAGE UL CENTRAL 022 T+24 A+3 R=0
00190746007224COSMETIC VIRAGE UR CENTRAL 022 T+24 A+3 R=0
00190746007217COSMETIC VIRAGE LL CUSPID 018 T-5 A+5 R5M W/HK DIST
00190746007200COSMETIC VIRAGE LR CUSPID 018 T-5 A+5 R5M W/HK DIST
00190746007194COSMETIC VIRAGE MAND ANTERIOR 018 T+3 A=0 R=0
00190746007187COSMETIC VIRAGE UL CUSPID 018 T+8 A+9 R5M W/HK DIST
00190746007170COSMETIC VIRAGE UR CUSPID 018 T+8 A+9 R5M W/HK DIST
00190746007163COSMETIC VIRAGE UL LATERAL 018 T+18 A+6 R=0
00190746007156COSMETIC VIRAGE UR LATERAL 018 T+18 A+6 R=0

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