NJM · Class II · 21 CFR 872.5470

FDA Product Code NJM: Bracket, Ceramic, Orthodontic

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.

Leading manufacturers include Tomy, Inc., Lightforce Orthodontics and American Orthodontics.

60
Total
60
Cleared
111d
Avg days
1990
Since
60 devices
25–48 of 60
Cleared Aug 26, 2016
ORTHODONTIC CERAMIC BRACKETS 1.1
K160615
Tomy, Inc.
Dental · 176d
Cleared May 27, 2016
BIJOU Orthodontic Ceramic Bracket
K152167
World Bio Tech Co., Ltd.
Dental · 297d
Cleared Nov 25, 2015
Avex CX2
K152779
Opal Orthodontics by Ultradent Products
Dental · 61d
Cleared Oct 23, 2015
Orthodontics Bracket
K150141
Speed Dental Co., Ltd.
Dental · 274d
Cleared May 15, 2015
Chi Lites Orthodontic Sapphire Bracket
K142729
Progressive Technology, Inc.
Dental · 234d
Cleared Jun 25, 2014
TRUKLEAR BRACKET
K141104
Ajw Technology Consultants, Inc.
Dental · 57d
Cleared Dec 19, 2013
VAPOR CERAMIC BRACKET
K132368
Orthodontic Design and Production, Inc.
Dental · 142d
Cleared Aug 27, 2013
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
K131197
Dental Morelli
Dental · 123d
Cleared Jun 07, 2013
FASTBRACES CERAMIC BRACKETS
K130446
Orthodontic Design and Production, Inc.
Dental · 106d
Cleared Dec 21, 2012
CERAMIN BRACKETS Z
K123092
Tomy, Inc.
Dental · 80d
Cleared Dec 14, 2012
EMPOWER CLEAR
K122753
American Orthodontics
Dental · 98d
Cleared Dec 13, 2012
ORTHODONTIC CERAMIC BRACKETS
K123094
Tomy, Inc.
Dental · 72d
Cleared Jun 04, 2012
MACH BRACKETS BRIGHT BRACKETS
K120471
World Bio Tech Co., Ltd.
Dental · 109d
Cleared Feb 03, 2012
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
K113334
Opal Orthodontics by Ultradent Products, Inc.
Dental · 81d
Cleared Jan 13, 2012
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
K112707
Ortho Technology, Inc.
Dental · 116d
Cleared May 19, 2011
CERAMIC BRACKETS
K110335
Ortho Organizers, Inc.
Dental · 104d
Cleared May 13, 2011
CLICK-IT
K111234
Tp Orthodontics, Inc.
Dental · 11d
Cleared Feb 17, 2011
CLARITY ADVANCED CERAMIC BRACKETS
K102803
3M Unitek Corporation
Dental · 142d
Cleared Jan 25, 2011
ORTHODONTIC CERAMIC BRACKET
K102561
Ht Co., Ltd.
Dental · 140d
Cleared Jun 23, 2010
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
K101481
Biomers Products, LLC
Dental · 26d
Cleared Aug 07, 2009
CDB FLIP-SIDE-CLIP BRACKET
K091702
Cdb Corporation
Dental · 58d
Cleared Jun 05, 2009
BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
K090933
Forestadent Bernhard Forster GmbH
Dental · 64d
Cleared May 27, 2009
ORTHODONTIC CERAMIC BRACKET
K090567
Star Dentech Korea., Corp
Dental · 85d
Cleared Mar 20, 2009
ALLURE MB CERAMIC BRACKETS
K090454
Dentsply Interntional
Dental · 25d