Not currently registered with FDA under this name
3M Unitek Corporation
Monrovia, CA, United States. Named as applicant on 9 dental 510(k) clearances between 1995 and 2017. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 91995–2017
- Markets registered in
- 10560 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 10 markets
Where regulators' registries name 3M Unitek Corporation 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 Corporation | 9 clearances | 1995–2017 | Below |
| Thailand | Thai FDA | Manufacturer | 3M UNITEK CORPORATION | 275 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | 3M Unitek Corporation3M/UNITEK · 3M Unitek Corp. · +2 | 129 | 1998–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | 3M UNITEK CORPORATION | 55 | 2003–2018 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | 3M UNITEK Corporation3M Unitek · 3M UNITEK Corporation. | 34 | — | Pure Global AI |
| Australia | TGA | Manufacturer | 3M Unitek | 27 | 2004–2018 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | 3M UNITEK CORPORATION3M UNITEK | 25 | 1999–2020 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | 3M Unitek Corporation | 13 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | 3M Unitek Corporation | 1 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | 3M Unitek Corporation | 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 Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Jan 2017 | K163689 | 3M Clear Tray Aligner | NXC Sequential Aligner |
| 2 Feb 2012 | K113197 | APC FLASH-FREE ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 17 Feb 2011 | K102803 | CLARITY ADVANCED CERAMIC BRACKETS | NJM Orthodontic Ceramic Bracket |
| 27 Jul 2010 | K100536 | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 15 Feb 2008 | K073697 | TRANSBOND SUPREME ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 18 Oct 2006 | K062305 | CLARITY MODIFIED CERAMIC BRACKETS | NJM Orthodontic Ceramic Bracket |
| 12 Apr 2002 | K020394 | APC PLUS ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 28 Feb 2002 | K014142 | UNITE BONDING ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 7 Mar 1995 | K950514 | TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT | DYH Resin Bracket and Tooth Conditioner Adhesive |
Some of these clearances are listed with FDA today by another company: Solventum US LLC (5).
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.