FDA product code DYW: Bracket, Plastic, Orthodontic
DYW is the FDA product code for bracket, plastic, orthodontic. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel. FDA has cleared 42 510(k) submissions under DYW, 2 in the last five years, from 29 different applicants. The average 510(k) review took 118 days (median 76); 47 days on average over the last three years. FDA has posted 5 recalls for DYW devices.
Classification
| Field | Value |
|---|---|
| Device name | Bracket, Plastic, Orthodontic |
| Device class | Class II |
| Regulation | 21 CFR 872.5470 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DYW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 149 |
| 2020 | 1 | 143 |
| 2025 | 2 | 47 |
Compare with all 510(k) review times · Search every DYW clearance
Top DYW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ormco Corp. | 9 | 2013-03-26 |
| Ultradent Products, Inc. | 3 | 2007-05-03 |
| Ortho Organizers, Inc. | 2 | 2025-11-27 |
| Sybron Dental Specialties, Inc. | 2 | 2003-10-15 |
| Unitek Corp. | 2 | 1994-11-29 |
24 more applicants have DYW clearances. See the full list in Caduvo.
Most recent DYW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252760 | Ortho Organizers, Inc. | Carriere® Motion Pro® Clear Bite Corrector | 2025-11-27 | 90 |
| K251196 | Ec Certification Service GmbH | Composite Orthodontic Brackets and Buttons | 2025-04-21 | 4 |
| K201940 | Braces on Demand, Inc. | Braces on Demand Bracket | 2020-12-03 | 143 |
| K182338 | Blue Sky Bio | Blue Sky Bio Computerized Orthodontic Bracket System | 2018-11-09 | 73 |
| K180718 | Tomy, Inc. | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | 2018-10-30 | 225 |
Recalls for DYW devices
5 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-03-25.
Frequently asked questions
What is FDA product code DYW?
DYW is the FDA product code for bracket, plastic, orthodontic. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel.
What device class is DYW?
Class II, regulation 21 CFR 872.5470. Typical premarket route: 510(k).
How long does a 510(k) take for product code DYW?
Across 42 cleared submissions the average was 118 days from receipt to decision (median 76).
Which companies have the most DYW clearances?
Ormco Corp. (9); Ultradent Products, Inc. (3); Ortho Organizers, Inc. (2); Sybron Dental Specialties, Inc. (2); Unitek Corp. (2).
Have DYW devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2014-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code DYW
- Run a recall and safety report across every DYW manufacturer
- Watch product code DYW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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