Product code DYW
- Device name
- Bracket, Plastic, Orthodontic
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.5470
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | 2025-11-27 |
| K251196 | Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH | 2025-04-21 |
| K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | 2020-12-03 |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | Blue Sky Bio | 2018-11-09 |
| K180718 | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | Tomy, Inc. | 2018-10-30 |
| K160720 | Carriere Motion Clear Class II | Ortho Organizers, Inc. | 2016-11-28 |
| K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | 2016-08-26 |
| K150702 | Exceed Tx | Great Lakes Orthodontics, Ltd. | 2016-03-24 |
| K140807 | COMPOSITE ORTHODONTIC BRACKETS | Ortho Specialties | 2014-11-12 |
| K123118 | INSIGNIA DIGICAST | Ormco Corp. | 2013-03-26 |
| K123416 | INSIGNIA WITH ITERO | Ormco Corp. | 2013-03-13 |
| K121524 | INSIGNIA | Ormco Corp. | 2012-08-09 |
| K110796 | SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE | Biomers Products, LLC | 2011-03-31 |
| K101676 | CLEARARCH | Ormco Corp. | 2010-09-13 |
| K082207 | ORTHOCAD IQ | Cadent, Inc. | 2009-10-23 |
| K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET | Dentsply Interntional | 2009-07-24 |
| K081143 | BIOMERS TRANSLUCENT ORTHODONTIC WIRE | Biomers Product, LLC | 2008-05-02 |
| K071055 | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 | Ultradent Products, Inc. | 2007-05-03 |
| K061042 | LINGLOCK | Sybron Dental Specialties | 2007-01-19 |
| K051953 | EVERSTICK A&O | Stick Tech , Ltd. | 2006-03-21 |
| K053055 | ORTHODONTIC POLYMER COMPOSITE BRACKET | Gestenco International AB | 2005-12-22 |
| K052477 | DAMON 3 MODIFIED | Ormco Corp. | 2005-11-30 |
| K052370 | CP BRACKET SYSTEM | Dentsply International | 2005-11-01 |
| K052714 | RAVE COMPOSITE BRACKET | FDA Agents | 2005-10-26 |
| K050730 | MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM | Ultradent Products, Inc. | 2005-03-31 |
| K032625 | ORTHODONTIC COMPOSITE BRACKET SYSTEM | Ultradent Products, Inc. | 2004-02-26 |
| K032408 | DAMON FT | Sybron Dental Specialties, Inc. | 2003-10-15 |
| K981433 | ORTHODONTIC BRACES | Midwest Orthodontic Mfg. | 1998-06-25 |
| K973776 | REFLECTIONS | Cdb Corp. | 1997-11-21 |
| K955333 | SPIRIT MB | Ormco Corp. | 1996-01-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D82966501920000101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665020200M0051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966502020000501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966502020000101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966502020000051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665019210M0501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665019210M0101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665019210M0051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501921000501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501921000101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501921000051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665019200M0501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665019200M0101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665019200M0051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501920000501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665016200M0101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501920000051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665018200M0501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665018200M0101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665018200M0051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501820000501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501820000101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501820000051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665017200M0501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665017200M0101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665017200M0051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501720000501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501720000101 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D82966501720000051 | Premium Line | EC Certification Service GmbH | 2026-05-28 |
| D829665016200M0501 | Premium Line | EC Certification Service GmbH | 2026-05-28 |