Manufacturer registered with FDA
Primo Medical Group, Inc
Stoughton, MA, United States. Lists 4 dental device types with FDA across 2 registered establishments.
- Device types listed
- 4
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 2United States
Registered in 3 markets
Where regulators' registries name Primo Medical Group, Inc as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Primo Medical Group, Inc | 4 device types | — | Below |
| South Korea | MFDS | Manufacturer | Primo Medical Group, Inc. | 1 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Primo Medical Group, Inc. | 1 | 2018–2018 | 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
Devices listed with FDA
What Primo Medical Group, Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | — | 2013 |
| Preformed AnchorEJX · Class 1 | — | Maker | Preformed Anchor | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Scan abutment | 2013 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Primo Medical Group, IncFDA reg. 3009420598 | W Bridgewater, MA, United States | Contract manufacturer |
| Primo Medical Group, INCFDA reg. 1222928 | STOUGHTON, MA, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9004401). 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.