DYW — Bracket, Plastic, Orthodontic Class II
FDA Device Classification
Classification Details
- Product Code
- DYW
- Device Class
- Class II
- Regulation Number
- 872.5470
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K252760 | ortho organizers | Carriere® Motion Pro® Clear Bite Corrector | November 27, 2025 |
| K251196 | ec certification service | Composite Orthodontic Brackets and Buttons | April 21, 2025 |
| K201940 | braces on demand | Braces on Demand Bracket | December 3, 2020 |
| K182338 | blue sky bio | Blue Sky Bio Computerized Orthodontic Bracket System | November 9, 2018 |
| K180718 | tomy | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | October 30, 2018 |
| K160720 | ortho organizers | Carriere Motion Clear Class II | November 28, 2016 |
| K150830 | oracrew | CompleClear Plastic Orthodontic Bracket and Wire Appliance | August 26, 2016 |
| K150702 | great lakes orthodontics | Exceed Tx | March 24, 2016 |
| K140807 | ortho specialties | COMPOSITE ORTHODONTIC BRACKETS | November 12, 2014 |
| K123118 | ormco | INSIGNIA DIGICAST | March 26, 2013 |
| K123416 | ormco | INSIGNIA WITH ITERO | March 13, 2013 |
| K121524 | ormco | INSIGNIA | August 9, 2012 |
| K110796 | biomers products | SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE | March 31, 2011 |
| K101676 | ormco | CLEARARCH | September 13, 2010 |
| K082207 | cadent | ORTHOCAD IQ | October 23, 2009 |
| K092030 | dentsply interntional | ELATION MB METAL REINFORCED PLASTIC BRACKET | July 24, 2009 |
| K081143 | biomers product | BIOMERS TRANSLUCENT ORTHODONTIC WIRE | May 2, 2008 |
| K071055 | ultradent products | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803 | May 3, 2007 |
| K061042 | sybron dental specialties | LINGLOCK | January 19, 2007 |
| K051953 | stick tech | EVERSTICK A&O | March 21, 2006 |