Not currently registered with FDA under this name
3M Healthcare
Saint Paul, MN, United States. Named as applicant on 1 dental 510(k) clearance between 2018 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12018–2018
- Markets registered in
- 6128 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name 3M Healthcare 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 Healthcare | 1 clearances | 2018–2018 | Below |
| Colombia | INVIMA | Manufacturer | 3M HEALTH CARE | 41 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | 3M Health Care | 32 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | 3M HEALTH CARE | 27 | 1995–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | 3M HEALTH CARE3M Health Care | 21 | 1993–2023 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | 3M HEALTH CARE | 7 | 2008–2023 | 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 Healthcare as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Mar 2018 | K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | NJM Orthodontic Ceramic Bracket |
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.