Empower Clear® 1475-18-230HD

GUDID 00190746141874

COSMETIC SL EMPOWER CLEAR INTERACT UL CUSPID 018 T=0 A+8 R=0 W/HK DIST

AMERICAN ORTHODONTICS CORPORATION

Self-ligating orthodontic bracket
Primary Device ID00190746141874
NIH Device Record Keya0d09048-330a-4549-938c-502822d593df
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmpower Clear®
Version Model Number1475-18-230HD
Catalog Number1475-18-230HD
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

Phone800-558-7687
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
GS100190746141874 [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 Date2019-01-28
Device Publish Date2018-12-28

Devices Manufactured by AMERICAN ORTHODONTICS CORPORATION

00190746064968 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE LIGHT 100g 9MM WITH EYELET 10/PK
00190746064975 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE LIGHT 100g 12MM WITH EYELET 10/PK
00190746064982 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE MED 150g 9MM WITH EYELET 10/PK
00190746064999 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE MED 150g 12MM WITH EYELET 10/PK
00190746065002 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE HEAVY 200g 9MM WITH EYELET 10/PK
00190746065026 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE HEAVY 200g 12MM WITH EYELET 10/PK
00190746065033 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE XHVY 250g 9MM WITH EYELET 10/PK
00190746065040 - NiTi Spring2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE XHVY 250g 12MM WITH EYELET 10/PK

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