DYW
- Product code
- DYW
- Device name
- Bracket, Plastic, Orthodontic
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.5470
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 42
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252760 | 2025-11-27 | Ortho Organizers, Inc. | Carriere® Motion Pro® Clear Bite Corrector | |
| K251196 | 2025-04-21 | Ec Certification Service GmbH | Composite Orthodontic Brackets and Buttons |
Official FDA classification page: DYW
Classification and pathway per current FDA publications. Data from openFDA (CC0).