Not currently registered with FDA under this name
3M Unitek Orthodontic Products
Monrovia, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2023 and 2023. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12023–2023
- Markets registered in
- 775 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name 3M Unitek Orthodontic Products as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | 3M Unitek Orthodontic Products | 1 clearances | 2023–2023 | Below |
| United Kingdom | MHRA | Manufacturer | 3M Unitek Orthodontic Products | 32 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | 3M Unitek Orthodontic Products | 15 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | 3M UNITEK ORTHODONTIC PRODUCTS | 13 | 2008–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | 3M UNITEK ORTHODONTIC PRODUCTS | 13 | 2007–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | 3M Unitek Orthodontic Products | 1 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | 3M Unitek Orthodontic Products | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names 3M Unitek Orthodontic Products as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Dec 2023 | K234043 | 3M Transbond Orthodontic Adhesive | DYH Resin Bracket and Tooth Conditioner Adhesive |
Some of these clearances are listed with FDA today by another company: Solventum US LLC (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.