Bracket, Plastic, Orthodontic
Regulation 872.5470
1510(k)s in 12 months (42 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in DYW
| Company | 510(k)s | Recalls |
|---|---|---|
| Ormco Corp. | 9 | 4 |
| Sybron Dental Specialties | 3 | 0 |
| Ultradent Products, Inc. | 3 | 0 |
| Ortho Organizers, Inc. | 2 | 0 |
| Unitek Corp. | 2 | 0 |
| Advanced Orthodontics Systems, Inc. | 1 | 0 |
| American Orthodontics | 1 | 0 |
| Biomers Product, LLC | 1 | 0 |
| Biomers Products, LLC | 1 | 0 |
| Blue Sky Bio | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 2025 | K252760 | Carriere® Motion Pro® Clear Bite Corrector Ortho Organizers, Inc. | DYW |
| Apr 21, 2025 | K251196 | Composite Orthodontic Brackets and Buttons Ec Certification Service GmbH, AT | DYW |
| Dec 3, 2020 | K201940 | Braces on Demand Bracket Braces on Demand, Inc. | DYW |
| Nov 9, 2018 | K182338 | Blue Sky Bio Computerized Orthodontic Bracket System Blue Sky Bio | DYW |
| Oct 30, 2018 | K180718 | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES Tomy, Inc., JP | DYW |
| Nov 28, 2016 | K160720 | Carriere Motion Clear Class II Ortho Organizers, Inc. | DYW |
| Aug 26, 2016 | K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance Oracrew | DYW |
| Mar 24, 2016 | K150702 | Exceed Tx Great Lakes Orthodontics, Ltd. | DYW |
| Nov 12, 2014 | K140807 | COMPOSITE ORTHODONTIC BRACKETS Ortho Specialties | DYW |
| Mar 26, 2013 | K123118 | INSIGNIA DIGICAST Ormco Corp. | DYW |
| Mar 13, 2013 | K123416 | INSIGNIA WITH ITERO Ormco Corp. | DYW |
| Aug 9, 2012 | K121524 | INSIGNIA Ormco Corp. | DYW |
| Mar 31, 2011 | K110796 | SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE Biomers Products, LLC, CA | DYW |
| Sep 13, 2010 | K101676 | CLEARARCH Ormco Corp. | DYW |
| Oct 23, 2009 | K082207 | ORTHOCAD IQ Cadent, Inc. | DYW |
| Jul 24, 2009 | K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET Dentsply Interntional | DYW |
| May 2, 2008 | K081143 | BIOMERS TRANSLUCENT ORTHODONTIC WIRE Biomers Product, LLC | DYW |
| May 3, 2007 | K071055 | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 Ultradent Products, Inc. | DYW |
| Jan 19, 2007 | K061042 | LINGLOCK Sybron Dental Specialties | DYW |
| Mar 21, 2006 | K051953 | EVERSTICK A&O Stick Tech , Ltd. | DYW |
| Dec 22, 2005 | K053055 | ORTHODONTIC POLYMER COMPOSITE BRACKET Gestenco International AB, SE | DYW |
| Nov 30, 2005 | K052477 | DAMON 3 MODIFIED Ormco Corp. | DYW |
| Nov 1, 2005 | K052370 | CP BRACKET SYSTEM Dentsply International | DYW |
| Oct 26, 2005 | K052714 | RAVE COMPOSITE BRACKET FDA Agents | DYW |
| Mar 31, 2005 | K050730 | MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM Ultradent Products, Inc. | DYW |
| Feb 26, 2004 | K032625 | ORTHODONTIC COMPOSITE BRACKET SYSTEM Ultradent Products, Inc. | DYW |
| Oct 15, 2003 | K032408 | DAMON FT Sybron Dental Specialties, Inc. | DYW |
| Jun 25, 1998 | K981433 | ORTHODONTIC BRACES Midwest Orthodontic Mfg. | DYW |
| Nov 21, 1997 | K973776 | REFLECTIONS Cdb Corp. | DYW |
| Jan 4, 1996 | K955333 | SPIRIT MB Ormco Corp. | DYW |
| Jul 19, 1995 | K951239 | GLOWING SPIRITS Ormco Corp. | DYW |
| Dec 14, 1994 | K942826 | ORTHODONITC METAL REINFORCED PLASTIC BRACKET Gac Intl., Inc. | DYW |
| Nov 29, 1994 | K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET Unitek Corp. | DYW |
| Aug 23, 1994 | K943245 | SPIRIT MB Sybron Dental Specialties, Inc. | DYW |
| Aug 24, 1993 | K932920 | GLENROE PLASTIC BRACKET Glenroe Technologies | DYW |
| Jun 28, 1990 | K900809 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS Lee Pharmaceuticals | DYW |
| Mar 8, 1990 | K896913 | SPIRIT Ormco Corp. | DYW |
| Mar 31, 1989 | K891372 | ORTHODONTIC PLASTIC BRACKET American Orthodontics | DYW |
| Dec 29, 1987 | K874227 | PLASTIC BRACKETS Advanced Orthodontics Systems, Inc. | DYW |
| Jun 9, 1986 | K861965 | UNITEK CERAMIC BRACKET SYSTEM Unitek Corp. | DYW |
| Dec 19, 1980 | K802899 | CERAMIBOND Zulauf, Inc. | DYW |
| Mar 15, 1978 | K780239 | BRACKET, METAL REINFORCED PLASTIC Ormco Corp. | DYW |
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