Atlas FDA

NJM

60 FDA 510(k) clearances · Product code

90 daysmedian time to decision
238 days90th percentile
60clearances measured

FDA profile

Official device name
Bracket, Ceramic, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Medical specialty
Dental
Flags
Third-party review eligible
FDA definition
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.
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RecordFirmDate
LightForce Orthodontic System (K232827)Lightforce Orthodontics2023-09-14
Cleo (K232011)American Orthodontics2023-07-07
A-Line Advanced (K231635)Biocetec Co., Ltd.2023-06-06
DynaFlex Clear Brackets & Buttons (K230225)Dyna Flex2023-06-05
Ceramic Brackets Orthometric (K222847)Orthometric - Industria E Comercio DE Produtos Medicos2023-05-04
LightForce Orthodontic System (K222764)Lightforce Orthodontics2022-09-14
Vatech Clismile (K220689)Rayence Co., Ltd.2022-05-06
VENUS Bracket, ROSE Bracket (K201410)Gni Co., Ltd.2021-03-12
Luce Ceramic Bracket (K201038)Luce Castle Co., Ltd.2020-10-09
LightForce Orthodontic System (LFO System) (K200148)Lightforce Orthodontics2020-02-21
ROSA Bracket (K182672)Gni Co., Ltd.2019-11-15
Clear21 (K192202)World Class Technology Corporation2019-11-12
Mei Ceramic Bracket (K190608)Orthosun Co., Ltd.2019-11-04
Ceramic Bracket (K180952)Mem Dental Technology Co., Ltd.2019-06-07
S-Line (K182193)Biocetec Co., Ltd.2019-01-22
Signature Orthodontic System (K183542)Signature Orthodontics2019-01-02
Signature Orthodontic System (K181271)Signature Orthodontics2018-06-13
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System (K180404)3M Healthcare2018-03-16
Carriere SLX 3D Clear (K173440)Ortho Organizers, Inc.2018-03-08
Symetri Clear (K172845)Ormco Corporation2018-01-31
Inspire ICE aka Inspire ICE Clear Brackets (K171844)Ormco Corporation2017-07-18
C-Line Orthodontic Ceramic Bracket (K163467)Biocetec Co., Ltd.2017-06-14
Alpha Pure (K163117)Koroad America2017-05-09
CDB Self Ligating Bracket 8F (K160957)Cdb Corporation2016-09-27
ORTHODONTIC CERAMIC BRACKETS 1.1 (K160615)Tomy, Inc.2016-08-26
BIJOU Orthodontic Ceramic Bracket (K152167)World Bio Tech Co., Ltd.2016-05-27
Avex CX2 (K152779)Opal Orthodontics by Ultradent Products2015-11-25
Orthodontics Bracket (K150141)Speed Dental Co., Ltd.2015-10-23
Chi Lites Orthodontic Sapphire Bracket (K142729)Progressive Technology, Inc.2015-05-15
TRUKLEAR BRACKET (K141104)Ajw Technology Consultants, Inc.2014-06-25
VAPOR CERAMIC BRACKET (K132368)Orthodontic Design and Production, Inc.2013-12-19
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS (K131197)Dental Morelli2013-08-27
FASTBRACES CERAMIC BRACKETS (K130446)Orthodontic Design and Production, Inc.2013-06-07
CERAMIN BRACKETS Z (K123092)Tomy, Inc.2012-12-21
EMPOWER CLEAR (K122753)American Orthodontics2012-12-14
ORTHODONTIC CERAMIC BRACKETS (K123094)Tomy, Inc.2012-12-13
MACH BRACKETS BRIGHT BRACKETS (K120471)World Bio Tech Co., Ltd.2012-06-04
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS (K113334)Opal Orthodontics by Ultradent Products, Inc.2012-02-03
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM (K112707)Ortho Technology, Inc.2012-01-13
CERAMIC BRACKETS (K110335)Ortho Organizers, Inc.2011-05-19
CLICK-IT (K111234)Tp Orthodontics, Inc.2011-05-13
CLARITY ADVANCED CERAMIC BRACKETS (K102803)3M Unitek Corporation2011-02-17
ORTHODONTIC CERAMIC BRACKET (K102561)Ht Co., Ltd.2011-01-25
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET (K101481)Biomers Products, LLC2010-06-23
CDB FLIP-SIDE-CLIP BRACKET (K091702)Cdb Corporation2009-08-07
BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS (K090933)Forestadent Bernhard Forster GmbH2009-06-05
ORTHODONTIC CERAMIC BRACKET (K090567)Star Dentech Korea., Corp2009-05-27
ALLURE MB CERAMIC BRACKETS (K090454)Dentsply Interntional2009-03-20
MYSTIQUE MB CERAMIC BRACKETS (K082974)Dentsply Interntional2008-11-07
CDB CLIP (K080906)Cdb Corporation2008-10-17
DAMON 4CLEAR (K081415)Ormco Corp.2008-09-24
RADIANCE (K080749)American Orthodontics2008-08-04
SAPPHIRE CERAMIC BRACKET (K073045)Ortho Technology, Inc.2007-12-18
CLARITY MODIFIED CERAMIC BRACKETS (K062305)3M Unitek2006-10-18
IN-OVATION C (K060837)Dentsply International2006-04-10
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS (K052245)Lar Mfg., LLC2005-09-23
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY (K042905)Dentsply Intl.2004-11-04
ORTHODONTIC CERAMIC BRACKETS (K042178)Dentsply Intl.2004-08-30
CERAMAFLEX BRACKET SYSTEM (K950992)Tp Orthodontics, Inc.1995-05-03
INTRIGUE CERAMIC BRACKET (K902075)Lancer Orthodontics, Inc.1990-08-06

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