2040 Ceramic Brackets 002-1024

GUDID 00190746005275

COSMETIC 20/40 UL LATERAL 022 T+8 A+9 R=0

AMERICAN ORTHODONTICS CORPORATION

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Primary Device ID00190746005275
NIH Device Record Key28c61513-923c-41bb-ac67-74855f7680d2
Commercial Distribution StatusIn Commercial Distribution
Brand Name2040 Ceramic Brackets
Version Model Number002-1024
Catalog Number002-1024
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
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746005275 [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 Date2016-11-09

On-Brand Devices [2040 Ceramic Brackets]

00190746115424CERAM BRACKET MBT 022 W/HKS U/L 3X3 CERAM 4-6 METAL KIT
00190746006104COSMETIC 20/40 UL CUSPID 022 T-7 A+8 R=0 W/HK DIST
00190746006098COSMETIC 20/40 UR CUSPID 022 T-7 A+8 R=0 W/HK DIST
00190746006081COSMETIC 20/40 UL CUSPID 018 T-7 A+8 R=0 W/HK DIST
00190746006074COSMETIC 20/40 UR CUSPID 018 T-7 A+8 R=0 W/HK DIST
00190746006067COSMETIC 20/40 LL 2ND BICUSPID 022 T-17 A+2 R=0 W/HK DIST
00190746006050COSMETIC 20/40 LL 2ND BICUSPID 022 T-17 A+2 R=0
00190746006043COSMETIC 20/40 LR 2ND BICUSPID 022 T-17 A+2 R=0 W/HK DIST
00190746006036COSMETIC 20/40 LR 2ND BICUSPID 022 T-17 A+2 R=0
00190746006029COSMETIC 20/40 LL 1ST BICUSPID 022 T-12 A+2 R=0 W/HK DIST
00190746006012COSMETIC 20/40 LL 1ST BICUSPID 022 T-12 A+2 R=0
00190746006005COSMETIC 20/40 LR 1ST BICUSPID 022 T-12 A+2 R=0 W/HK DIST
00190746005992COSMETIC 20/40 LR 1ST BICUSPID 022 T-12 A+2 R=0
00190746005985COSMETIC 20/40 LL CUSPID 022 T=0 A+3 R=0 W/HK DIST
00190746005978COSMETIC 20/40 LL CUSPID 022 T=0 A+3 R=0
00190746005961COSMETIC 20/40 LR CUSPID 022 T=0 A+3 R=0 W/HK DIST
00190746005954COSMETIC 20/40 LR CUSPID 022 T=0 A+3 R=0
00190746005947COSMETIC 20/40 LL CUSPID 022 T-6 A+3 R=0 W/HK DIST
00190746005930COSMETIC 20/40 LR CUSPID 022 T-6 A+3 R=0 W/HK DIST
00190746005923COSMETIC 20/40 MAND ANTERIOR 022 T-6 A=0 R=0
00190746005916COSMETIC 20/40 UL BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746005909COSMETIC 20/40 UR BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746005893COSMETIC 20/40 MAX BICUSPID 022 T-7 A=0 R=0
00190746005886COSMETIC 20/40 UL CUSPID 022 T=0 A+8 R=0 W/HK DIST
00190746005879COSMETIC 20/40 UL CUSPID 022 T=0 A+8 R=0
00190746005862COSMETIC 20/40 UR CUSPID 022 T=0 A+8 R=0 W/HK DIST
00190746005855COSMETIC 20/40 UR CUSPID 022 T=0 A+8 R=0
00190746005848COSMETIC 20/40 UL LATERAL 022 T+10 A+8 R=0
00190746005831COSMETIC 20/40 UR LATERAL 022 T+10 A+8 R=0
00190746005824COSMETIC 20/40 UL CENTRAL 022 T+17 A+4 R=0
00190746005817COSMETIC 20/40 UR CENTRAL 022 T+17 A+4 R=0
00190746005800COSMETIC 20/40 LL 2ND BICUSPID 018 T-17 A+2 R=0 W/HK DIST
00190746005794COSMETIC 20/40 LL 2ND BICUSPID 018 T-17 A+2 R=0
00190746005787COSMETIC 20/40 LR 2ND BICUSPID 018 T-17 A+2 R=0 W/HK DIST
00190746005770COSMETIC 20/40 LR 2ND BICUSPID 018 T-17 A+2 R=0
00190746005763COSMETIC 20/40 LL 1ST BICUSPID 018 T-12 A+2 R=0 W/HK DIST
00190746005756COSMETIC 20/40 LL 1ST BICUSPID 018 T-12 A+2 R=0
00190746005749COSMETIC 20/40 LR 1ST BICUSPID 018 T-12 A+2 R=0 W/HK DIST
00190746005732COSMETIC 20/40 LR 1ST BICUSPID 018 T-12 A+2 R=0
00190746005725COSMETIC 20/40 LL CUSPID 018 T=0 A+3 R=0
00190746005718COSMETIC 20/40 LR CUSPID 018 T=0 A+3 R=0
00190746005701COSMETIC 20/40 LL CUSPID 018 T-6 A+3 R=0 W/HK DIST
00190746005695COSMETIC 20/40 LR CUSPID 018 T-6 A+3 R=0 W/HK DIST
00190746005688COSMETIC 20/40 MAND ANTERIOR 018 T-6 A=0 R=0
00190746005671COSMETIC 20/40 UL BICUSPID 018 T-7 A=0 R=0 W/HK DIST
00190746005664COSMETIC 20/40 UR BICUSPID 018 T-7 A=0 R=0 W/HK DIST
00190746005657COSMETIC 20/40 MAX BICUSPID 018 T-7 A=0 R=0
00190746005640COSMETIC 20/40 UL CUSPID 018 T=0 A+8 R=0
00190746005633COSMETIC 20/40 UR CUSPID 018 T=0 A+8 R=0
00190746005626COSMETIC 20/40 UL LATERAL 018 T+10 A+8 R=0
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