Bracket, Plastic, Orthodontic
FDA product code DYW · Class II (moderate risk) · 21 CFR 872.5470 · Dental
42510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Ormco Corp. 9
- Sybron Dental Specialties, Inc. 3
- Ultradent Products, Inc. 3
- Ortho Organizers, Inc. 2
- Unitek Corp. 2
- Midwest Orthodontic Mfg. 1
- Ec Certification Service GmbH 1
- Cadent, Inc. 1
- Dentsply Interntional 1
- Biomers Product, LLC 1
- Stick Tech , Ltd. 1
- Gestenco International AB 1
- Dentsply International, Inc. 1
- FDA Agents 1
- Cdb Corporation 1
- Gac Intl., Inc. 1
- Glenroe Technologies 1
- Lee Pharmaceuticals 1
- American Orthodontics 1
- Advanced Orthodontics Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite CorrectorDYW · Traditional | Ortho Organizers, Inc. | 11/27/2025SE |
| K251196 | Composite Orthodontic Brackets and ButtonsDYW · Traditional | Ec Certification Service GmbH | 04/21/2025SE |
| K201940 | Braces on Demand BracketDYW · Traditional | Braces on Demand, Inc. | 12/03/2020SE |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket SystemDYW · Traditional | Blue Sky Bio | 11/09/2018SE |
| K180718 | Orthodontic Plastic Brackets and AccessoriesDYW · Traditional | Tomy, Inc. | 10/30/2018SE |
| K160720 | Carriere Motion Clear Class IIDYW · Traditional | Ortho Organizers, Inc. | 11/28/2016SE |
| K150830 | CompleClear Plastic Orthodontic Bracket and Wire ApplianceDYW · Traditional | Oracrew | 08/26/2016SE |
| K150702 | Exceed TxDYW · Traditional | Great Lakes Orthodontics, Ltd. | 03/24/2016SE |
| K140807 | Composite Orthodontic BracketsDYW · Traditional | Ortho Specialties | 11/12/2014SE |
| K123118 | Insignia DigicastDYW · Traditional | Ormco Corp. | 03/26/2013SE |
| K123416 | Insignia with IteroDYW · Traditional | Ormco Corp. | 03/13/2013SE |
| K121524 | InsigniaDYW · Traditional | Ormco Corp. | 08/09/2012SE |
| K110796 | Simpliclear Rectangular Orthodontic WireDYW · Traditional | Biomers Products, LLC | 03/31/2011SE |
| K101676 | CleararchDYW · Traditional | Ormco Corp. | 09/13/2010SE |
| K082207 | Orthocad IqDYW · Traditional | Cadent, Inc. | 10/23/2009SE |
| K092030 | Elation MB Metal Reinforced Plastic BracketDYW · Special | Dentsply Interntional | 07/24/2009SE |
| K081143 | Biomers Translucent Orthodontic WireDYW · Traditional | Biomers Product, LLC | 05/02/2008SE |
| K071055 | Opal Prime & Opal Bond/Orthodontic Bracket System, Models 2626, 2625, 2635, 2803, 2802DYW · Special | Ultradent Products, Inc. | 05/03/2007SE |
| K061042 | LinglockDYW · Traditional | Sybron Dental Specialties | 01/19/2007SE |
| K051953 | Everstick A&ODYW · Traditional | Stick Tech , Ltd. | 03/21/2006SE |
| K053055 | Orthodontic Polymer Composite BracketDYW · Traditional | Gestenco International AB | 12/22/2005SE |
| K052477 | Damon 3 ModifiedDYW · Traditional | Ormco Corp. | 11/30/2005SE |
| K052370 | CP Bracket SystemDYW · Traditional | Dentsply International | 11/01/2005SE |
| K052714 | Rave Composite BracketDYW · Traditional | FDA Agents | 10/26/2005SE |
| K050730 | Modification to Orthodontic Composite Bracket SystemDYW · Special | Ultradent Products, Inc. | 03/31/2005SE |
| K032625 | Orthodontic Composite Bracket SystemDYW · Traditional | Ultradent Products, Inc. | 02/26/2004SE |
| K032408 | Damon FTDYW · Traditional | Sybron Dental Specialties, Inc. | 10/15/2003SE |
| K981433 | Orthodontic BracesDYW · Traditional | Midwest Orthodontic Mfg. | 06/25/1998SE |
| K973776 | ReflectionsDYW · Traditional | Cdb Corp. | 11/21/1997SE |
| K955333 | Spirit MBDYW · Traditional | Ormco Corp. | 01/04/1996SE |
| K951239 | Glowing SpiritsDYW · Traditional | Ormco Corp. | 07/19/1995SE |
| K942826 | Orthodonitc Metal Reinforced Plastic BracketDYW · Traditional | Gac Intl., Inc. | 12/14/1994SE |
| K944286 | Metal-Lined Transcend Ceramic BracketDYW · Traditional | Unitek Corp. | 11/29/1994SE |
| K943245 | Spirit MBDYW · Traditional | Sybron Dental Specialties, Inc. | 08/23/1994SE |
| K932920 | Glenroe Plastic BracketDYW · Traditional | Glenroe Technologies | 08/24/1993SE |
| K900809 | Lee-Fischer Ceramic Reinforced Plastic BracketsDYW · Traditional | Lee Pharmaceuticals | 06/28/1990SE |
| K896913 | SpiritDYW · Traditional | Ormco Corp. | 03/08/1990SE |
| K891372 | Orthodontic Plastic BracketDYW · Traditional | American Orthodontics | 03/31/1989SE |
| K874227 | Plastic BracketsDYW · Traditional | Advanced Orthodontics Systems, Inc. | 12/29/1987SE |
| K861965 | Unitek Ceramic Bracket SystemDYW · Traditional | Unitek Corp. | 06/09/1986SE |
| K802899 | CeramibondDYW · Traditional | Zulauf, Inc. | 12/19/1980SE |
| K780239 | Bracket, Metal Reinforced PlasticDYW · Traditional | Ormco Corp. | 03/15/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1330-2014 Class II | Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013.…Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013… | Ormco/Sybronendo | 03/25/2014Terminated |
| Z-0201-2012 | Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets…Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. | Ormco Corporation | 05/18/2011Terminated |
| Z-0200-2012 | Spirit MB Brackets, part #494-1210. The brand name of the device is Spirit MB Brackets…Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. | Ormco Corporation | 05/18/2011Terminated |