FDA 510(k) Applications for Medical Device Product Code "DYW"
(Bracket, Plastic, Orthodontic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K081143 | BIOMERS PRODUCT, LLC | BIOMERS TRANSLUCENT ORTHODONTIC WIRE | 05/02/2008 |
| K110796 | BIOMERS PRODUCTS, LLC | SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE | 03/31/2011 |
| K182338 | Blue Sky Bio | Blue Sky Bio Computerized Orthodontic Bracket System | 11/09/2018 |
| K201940 | Braces on Demand, Inc | Braces on Demand Bracket | 12/03/2020 |
| K082207 | CADENT, INC. | ORTHOCAD IQ | 10/23/2009 |
| K973776 | CDB CORP. | REFLECTIONS | 11/21/1997 |
| K052370 | DENTSPLY INTERNATIONAL | CP BRACKET SYSTEM | 11/01/2005 |
| K092030 | DENTSPLY INTERNTIONAL | ELATION MB METAL REINFORCED PLASTIC BRACKET | 07/24/2009 |
| K251196 | EC Certification Service GmbH | Composite Orthodontic Brackets and Buttons | 04/21/2025 |
| K052714 | FDA AGENTS | RAVE COMPOSITE BRACKET | 10/26/2005 |
| K053055 | GESTENCO INTERNATIONAL AB | ORTHODONTIC POLYMER COMPOSITE BRACKET | 12/22/2005 |
| K150702 | GREAT LAKES ORTHODONTICS, LTD. | Exceed Tx | 03/24/2016 |
| K981433 | MIDWEST ORTHODONTIC MFG. | ORTHODONTIC BRACES | 06/25/1998 |
| K150830 | ORACREW | CompleClear Plastic Orthodontic Bracket and Wire Appliance | 08/26/2016 |
| K101676 | ORMCO CORP. | CLEARARCH | 09/13/2010 |
| K052477 | ORMCO CORP. | DAMON 3 MODIFIED | 11/30/2005 |
| K121524 | ORMCO CORP. | INSIGNIA | 08/09/2012 |
| K123118 | ORMCO CORP. | INSIGNIA DIGICAST | 03/26/2013 |
| K123416 | ORMCO CORP. | INSIGNIA WITH ITERO | 03/13/2013 |
| K955333 | ORMCO CORP. | SPIRIT MB | 01/04/1996 |
| K160720 | ORTHO ORGANIZERS, INC. | Carriere Motion Clear Class II | 11/28/2016 |
| K140807 | ORTHO SPECIALTIES | COMPOSITE ORTHODONTIC BRACKETS | 11/12/2014 |
| K051953 | STICK TECH LTD. | EVERSTICK A&O | 03/21/2006 |
| K061042 | SYBRON DENTAL SPECIALTIES | LINGLOCK | 01/19/2007 |
| K032408 | SYBRON DENTAL SPECIALTIES, INC. | DAMON FT | 10/15/2003 |
| K180718 | TOMY, Inc. | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | 10/30/2018 |
| K050730 | ULTRADENT PRODUCTS, INC. | MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM | 03/31/2005 |
| K071055 | ULTRADENT PRODUCTS, INC. | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 | 05/03/2007 |
| K032625 | ULTRADENT PRODUCTS, INC. | ORTHODONTIC COMPOSITE BRACKET SYSTEM | 02/26/2004 |
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