Bracket, Ceramic, Orthodontic
Dental · 21 CFR 872.5470
An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.
Recent MDR events
23 adverse event reports on file
- 3M¿ CLARITY¿ ADVANCED CERAMIC BRACKETS, APC¿ FLASH-FREEMar 12, 2025Injury3m Unitek Corporation2020467-2025-00002
- LIGHTFORCE ORTHODONTIC SYSTEMOct 29, 2024MalfunctionLightforce OrthodonticsMW5161849
- LIGHTFORCE ORTHODONTIC SYSTEMMay 7, 2024InjuryLightforce Orthodontics3013770639-2024-00001
- CARRIERE SLX 3D CLEARSep 29, 2023InjuryOrtho Organizers, Inc.2081322-2023-00001
- CLEAR-VIZ MINI BRACKETJul 7, 2020InjuryDynaflex0001937100-2020-00001
- 3M UNITEK APC II¿ CLARITY¿ ADVANCED MBT CERAMIC BRACKETJun 22, 2018Injury3m Unitek Corporation2020467-2018-00003
- 3M UNITEK APC II¿ CLARITY¿ ADVANCED MBT CERAMIC BRACKETJun 22, 2018Injury3m Unitek Corporation2020467-2018-00001
- 3M UNITEK APC¿ FLASH-FREE CLARITY¿ ADVANCED MBTDec 20, 2017Injury3m Unitek Corporaion2020467-2017-00007
- BRACES (DAMON CERAMIC BRACES)Nov 1, 2017InjuryOrmco CorporationMW5073068
- APC(TM) FLASH-FREE CLARITY(TM) ADVANCED CERAMIC BRACKETOct 20, 2016Injury3m Unitek Corporation2020467-2016-00004
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
93 firms currently registered for this product code
Csy International Llc
Rancho Cucamonga, CA, US
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Young Innovations Inc.
Algonquin, IL, US
Ortho Solutions Lc
Lake Saint Louis, MO, US
Orthometric Ind. E Com. De Prod. Med. Odont.
Marilia Sao Paulo, BR
Cdb Corporation
Leland, NC, US
Ormco Corporation
Pomona, CA, US
World Bio Tech Co Ltd
Seongnam-si Gyeonggi, KR
G & H Wire Company
Franklin, IN, US
Gc Orthodontics America Inc.
Alsip, IL, US
Ormco Corporation
Brea, CA, US
Five Star Orthodontic Laboratory & Supply, Inc.
Denton, TX, US
Lightforce Orthodontics
Wilmington, MA, US
Fairfield Orthodontics, Llc
STRATFORD, CT, US
Solventum Poland Manufacturing Sp. Zo.o
Wroclaw Dolnoslaskie, PL
Rmo
Franklin, IN, US
Ortho Organizers, Inc.
Savannah, GA, US
Forestadent Bernhard Forster Gmbh
PFORZHEIM Baden-Wurttemberg, DE
Leone Spa
Sesto Fiorentino Firenze, IT
510(k) clearances
60 clearances for this product code
- Lightforce OrthodonticsSep 14, 2023
K232827 · LightForce Orthodontic System
- American OrthodonticsJul 7, 2023
K232011 · Cleo
- Biocetec Co., Ltd.Jun 6, 2023
K231635 · A-Line Advanced
- Dyna FlexJun 5, 2023
K230225 · DynaFlex Clear Brackets & Buttons
- Orthometric - Industria E Comercio DE Produtos MedicosMay 4, 2023
K222847 · Ceramic Brackets Orthometric
- Lightforce OrthodonticsSep 14, 2022
K222764 · LightForce Orthodontic System
- Rayence Co., Ltd.May 6, 2022
K220689 · Vatech Clismile
- Gni Co., Ltd.Mar 12, 2021
K201410 · VENUS Bracket, ROSE Bracket