DYH — Adhesive, Bracket And Tooth Conditioner, Resin Class II
FDA product code DYH covers "Adhesive, Bracket And Tooth Conditioner, Resin", a Class II medical device regulated under 21 CFR 872.3750. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DYH
- Device Class
- Class II
- Regulation Number
- 872.3750
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261129 | spident co | OrthoFit | July 2, 2026 |
| K261840 | american orthodontics | BracePaste Prime Plus | June 3, 2026 |
| K250015 | ormco corporation | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree | January 3, 2025 |
| K242537 | american orthodontics | BracePaste Fluoride Sealant | August 27, 2024 |
| K234043 | 3m unitek orthodontic products | 3M Transbond Orthodontic Adhesive | December 22, 2023 |
| K231817 | voco | AlignerFlow LC | December 1, 2023 |
| K214054 | tp orthodontics | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive | October 14, 2022 |
| K210115 | largent health | FiteBac CC OrthoSeal | July 29, 2021 |
| K192682 | dentscare ltda | Orthocem, Ortho Bite | August 14, 2020 |
| K202276 | american orthodontics | BracePaste Band and Build LC | August 14, 2020 |
| K193388 | reliance orthodontic products | GlassLok Kits, GlassLok Powder, GlassLok Liquid | April 27, 2020 |
| K183147 | voco | BrackFix | March 1, 2019 |
| K173020 | pulpdent corporation | OBA-MCP, Orthodontic Bracket Adhesive with MCP | January 17, 2018 |
| K160782 | american orthodontics | BracePaste Adhesive | October 14, 2016 |
| K161684 | reliance orthodontic products | Quantum LB | October 6, 2016 |
| K150128 | gc orthodontics america | GC Ortho Connect, GC Ortho Etching Gel | July 16, 2015 |
| K143667 | gc orthodontics america | GC KommonBase | May 7, 2015 |
| K142886 | danville materials | DMRC Self-Cure Bracket Adhesive One Step and Primer | March 18, 2015 |
| K142881 | danville materials | DMRC Dual Cure Orthodontic Band Cement | February 13, 2015 |
| K142880 | daville materials | DMRC Light Cure Orthodontic Adhesive System | February 4, 2015 |