DYH
- Product code
- DYH
- Device name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3750
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 194 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261129 | 2026-07-02 | Spident Co., Ltd. | OrthoFit | |
| K261840 | 2026-06-03 | American Orthodontics | BracePaste Prime Plus | |
| K250015 | 2025-01-03 | Ormco Corporation | Ormco EtchFree Bonding System, Ormco EtchFree Bond | |
| K242537 | 2024-08-27 | American Orthodontics Corp. | BracePaste Fluoride Sealant | |
| K234043 | 2023-12-22 | 3M Unitek Orthodontic Products | 3M Transbond Orthodontic Adhesive | |
| K231817 | 2023-12-01 | Voco GmbH | AlignerFlow LC | — |
Official FDA classification page: DYH
Classification and pathway per current FDA publications. Data from openFDA (CC0).