Empower Clear 1585-22-3517HD

GUDID 00190746060601

COSMETIC SL EMPOWER CLEAR PASSIVE LL 2ND BICUSPID 022 T-17 A+2 R=0 W/HK DIST

AMERICAN ORTHODONTICS CORPORATION

Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket Self-ligating orthodontic bracket
Primary Device ID00190746060601
NIH Device Record Keya1521d5a-346f-48c6-896f-5a1c242be638
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmpower Clear
Version Model Number1585-22-3517HD
Catalog Number1585-22-3517HD
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746060601 [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 Date2024-04-19
Device Publish Date2024-04-11

On-Brand Devices [Empower Clear]

00190746025617COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BICUSPID 022 T-12 A+2 R=0 W/HK DIST
00190746024832COSMETIC SL EMPOWER CLEAR INTERACT LR 2ND BICUSPID 022 T-12 A+2 R=0 W/HK DIST
00190746021473COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746021466COSMETIC SL EMPOWER CLEAR INTERACT LR 1ST BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746021459COSMETIC SL EMPOWER CLEAR INTERACT LL CUSPID 022 T-2 A+9 R=0 W/HK DIST
00190746021442COSMETIC SL EMPOWER CLEAR INTERACT LR CUSPID 022 T-2 A+9 R=0 W/HK DIST
00190746021435COSMETIC SL EMPOWER CLEAR INTERACT UL BICUSPID 022 T-12 A+2 R=0
00190746021428COSMETIC SL EMPOWER CLEAR INTERACT UR BICUSPID 022 T-12 A+2 R=0
00190746001130COSMETIC SL EMPOWER CLEAR PASSIVE LL ANTERIOR 022 T-1 A=0 R=0
00190746001123COSMETIC SL EMPOWER CLEAR INTERACT LR 2ND BICUSPID 022 T-22 A=0 R=0 W/HK DIST
00190746001116COSMETIC SL EMPOWER CLEAR INTERACT LR 2ND BICUSPID 022 T-22 A=0 R=0
00190746001109COSMETIC SL EMPOWER CLEAR INTERACT LR 2ND BICUSPID 022 T-17 A+2 R=0 W/HK DIST
00190746001093COSMETIC SL EMPOWER CLEAR INTERACT LR 2ND BICUSPID 022 T-17 A+2 R=0
00190746001086COSMETIC SL EMPOWER CLEAR INTERACT LR 1ST BICUSPID 022 T-17 A=0 R=0 W/HK DIST
00190746001079COSMETIC SL EMPOWER CLEAR INTERACT LR 1ST BICUSPID 022 T-17 A=0 R=0
00190746001062COSMETIC SL EMPOWER CLEAR INTERACT LR 1ST BICUSPID 022 T-12 A+2 R=0 W/HK DIST
00190746001055COSMETIC SL EMPOWER CLEAR INTERACT LR 1ST BICUSPID 022 T-12 A+2 R=0
00190746001048COSMETIC SL EMPOWER CLEAR INTERACT LR CUSPID 022 T-11 A+7 R=0 W/HK DIST
00190746001031COSMETIC SL EMPOWER CLEAR INTERACT LR CUSPID 022 T=0 A+3 R=0 W/HK DIST
00190746001024COSMETIC SL EMPOWER CLEAR INTERACT LR CUSPID 022 T-6 A+3 R=0 W/HK DIST
00190746001017COSMETIC SL EMPOWER CLEAR INTERACT LR ANTERIOR 022 T-6 A=0 R=0
00190746001000COSMETIC SL EMPOWER CLEAR INTERACT LR ANTERIOR 022 T-1 A=0 R=0
00190746000997COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BICUSPID 022 T-22 A=0 R=0 W/HK DIST
00190746000980COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BICUSPID 022 T-22 A=0 R=0
00190746000973COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BICUSPID 022 T-17 A+2 R=0 W/HK DIST
00190746000966COSMETIC SL EMPOWER CLEAR INTERACT LL 2ND BICUSPID 022 T-17 A+2 R=0
00190746000959COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BICUSPID 022 T-17 A=0 R=0 W/HK DIST
00190746000942COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BICUSPID 022 T-17 A=0 R=0
00190746000935COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BICUSPID 022 T-12 A+2 R=0 W/HK DIST
00190746000928COSMETIC SL EMPOWER CLEAR INTERACT LL 1ST BICUSPID 022 T-12 A+2 R=0
00190746000911COSMETIC SL EMPOWER CLEAR INTERACT LL CUSPID 022 T-11 A+7 R=0 W/HK DIST
00190746000904COSMETIC SL EMPOWER CLEAR INTERACT LL CUSPID 022 T=0 A+3 R=0 W/HK DIST
00190746000898COSMETIC SL EMPOWER CLEAR INTERACT LL CUSPID 022 T-6 A+3 R=0 W/HK DIST
00190746000881COSMETIC SL EMPOWER CLEAR INTERACT LL ANTERIOR 022 T-6 A=0 R=0
00190746000874COSMETIC SL EMPOWER CLEAR INTERACT LL ANTERIOR 022 T-1 A=0 R=0
00190746000867COSMETIC SL EMPOWER CLEAR INTERACT UL BICUSPID 022 T-7 A=0 R=0 W/HK UNV
00190746000850COSMETIC SL EMPOWER CLEAR INTERACT UL BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746000843COSMETIC SL EMPOWER CLEAR INTERACT UL BICUSPID 022 T-7 A=0 R=0
00190746000836COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 022 T=0 A+8 R=0 W/HK UNV
00190746000829COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 022 T=0 A+8 R=0 W/HK DIST
00190746000812COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 022 T-7 A+8 R=0 W/HK DIST
00190746000805COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 022 T-2 A+9 R=0 W/HK DIST
00190746000799COSMETIC SL EMPOWER CLEAR INTERACT UL LATERAL 022 T+8 A+9 R=0
00190746000782COSMETIC SL EMPOWER CLEAR INTERACT UL LATERAL 022 T+10 A+8 R=0
00190746000775COSMETIC SL EMPOWER CLEAR INTERACT UL CENTRAL 022 T+17 A+4 R=0
00190746000768COSMETIC SL EMPOWER CLEAR INTERACT UL CENTRAL 022 T+12 A+5 R=0
00190746000751COSMETIC SL EMPOWER CLEAR INTERACT UR BICUSPID 022 T-7 A=0 R=0 W/HK UNV
00190746000744COSMETIC SL EMPOWER CLEAR INTERACT UR BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746000737COSMETIC SL EMPOWER CLEAR INTERACT UR BICUSPID 022 T-7 A=0 R=0
00190746000720COSMETIC SL EMPOWER CLEAR INTERACT UR CUSPID 022 T=0 A+8 R=0 W/HK UNV
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