FDA Product Code
FDA Product Code DYW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5470
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | 2025-11-27 | Traditional | PDF ↗ |
| K251196 | Composite Orthodontic Brackets and Buttons | Ec Certification Service GmbH | 2025-04-21 | Traditional | PDF ↗ |
| K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | 2020-12-03 | Traditional | PDF ↗ |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | Blue Sky Bio | 2018-11-09 | Traditional | PDF ↗ |
| K180718 | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | Tomy, Inc. | 2018-10-30 | Traditional | PDF ↗ |
| K160720 | Carriere Motion Clear Class II | Ortho Organizers, Inc. | 2016-11-28 | Traditional | PDF ↗ |
| K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | 2016-08-26 | Traditional | PDF ↗ |
| K150702 | Exceed Tx | Great Lakes Orthodontics, Ltd. | 2016-03-24 | Traditional | PDF ↗ |
| K140807 | COMPOSITE ORTHODONTIC BRACKETS | Ortho Specialties | 2014-11-12 | Traditional | PDF ↗ |
| K123118 | INSIGNIA DIGICAST | Ormco Corp. | 2013-03-26 | Traditional | PDF ↗ |
| K123416 | INSIGNIA WITH ITERO | Ormco Corp. | 2013-03-13 | Traditional | PDF ↗ |
| K121524 | INSIGNIA | Ormco Corp. | 2012-08-09 | Traditional | PDF ↗ |
| K110796 | SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE | Biomers Products, LLC | 2011-03-31 | Traditional | PDF ↗ |
| K101676 | CLEARARCH | Ormco Corp. | 2010-09-13 | Traditional | PDF ↗ |
| K082207 | ORTHOCAD IQ | Cadent, Inc. | 2009-10-23 | Traditional | PDF ↗ |
| K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET | Dentsply Interntional | 2009-07-24 | Special | PDF ↗ |
| K081143 | BIOMERS TRANSLUCENT ORTHODONTIC WIRE | Biomers Product, LLC | 2008-05-02 | Traditional | PDF ↗ |
| K071055 | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 | Ultradent Products, Inc. | 2007-05-03 | Special | PDF ↗ |
| K061042 | LINGLOCK | Sybron Dental Specialties | 2007-01-19 | Traditional | PDF ↗ |
| K051953 | EVERSTICK A&O | Stick Tech , Ltd. | 2006-03-21 | Traditional | PDF ↗ |
| K053055 | ORTHODONTIC POLYMER COMPOSITE BRACKET | Gestenco International AB | 2005-12-22 | Traditional | PDF ↗ |
| K052477 | DAMON 3 MODIFIED | Ormco Corp. | 2005-11-30 | Traditional | PDF ↗ |
| K052370 | CP BRACKET SYSTEM | Dentsply International | 2005-11-01 | Traditional | PDF ↗ |
| K052714 | RAVE COMPOSITE BRACKET | FDA Agents | 2005-10-26 | Traditional | PDF ↗ |
| K050730 | MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM | Ultradent Products, Inc. | 2005-03-31 | Special | PDF ↗ |
| K032625 | ORTHODONTIC COMPOSITE BRACKET SYSTEM | Ultradent Products, Inc. | 2004-02-26 | Traditional | PDF ↗ |
| K032408 | DAMON FT | Sybron Dental Specialties, Inc. | 2003-10-15 | Traditional | PDF ↗ |
| K981433 | ORTHODONTIC BRACES | Midwest Orthodontic Mfg. | 1998-06-25 | Traditional | PDF ↗ |
| K973776 | REFLECTIONS | Cdb Corp. | 1997-11-21 | Traditional | PDF ↗ |
| K955333 | SPIRIT MB | Ormco Corp. | 1996-01-04 | Traditional | PDF ↗ |
| K951239 | GLOWING SPIRITS | Ormco Corp. | 1995-07-19 | Traditional | PDF ↗ |
| K942826 | ORTHODONITC METAL REINFORCED PLASTIC BRACKET | Gac Intl., Inc. | 1994-12-14 | Traditional | PDF ↗ |
| K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET | Unitek Corp. | 1994-11-29 | Traditional | PDF ↗ |
| K943245 | SPIRIT MB | Sybron Dental Specialties, Inc. | 1994-08-23 | Traditional | PDF ↗ |
| K932920 | GLENROE PLASTIC BRACKET | Glenroe Technologies | 1993-08-24 | Traditional | PDF ↗ |
| K900809 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS | Lee Pharmaceuticals | 1990-06-28 | Traditional | PDF ↗ |
| K896913 | SPIRIT | Ormco Corp. | 1990-03-08 | Traditional | PDF ↗ |
| K891372 | ORTHODONTIC PLASTIC BRACKET | American Orthodontics | 1989-03-31 | Traditional | PDF ↗ |
| K874227 | PLASTIC BRACKETS | Advanced Orthodontics Systems, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K861965 | UNITEK CERAMIC BRACKET SYSTEM | Unitek Corp. | 1986-06-09 | Traditional | PDF ↗ |
| K802899 | CERAMIBOND | Zulauf, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K780239 | BRACKET, METAL REINFORCED PLASTIC | Ormco Corp. | 1978-03-15 | Traditional | PDF ↗ |
Product code DYW · Class II · Dental. Data: openFDA.