Manufacturer registered with FDA
Millstone Medical Outsourcing LLC
Fall River, MA, United States. Lists 5 dental device types with FDA across 2 registered establishments.
- Device types listed
- 5
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 2United States
Registered in 3 markets
Where regulators' registries name Millstone Medical Outsourcing LLC 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 | Millstone Medical Outsourcing LLC | 5 device types | — | Below |
| South Korea | MFDS | Manufacturer | MILLSTONE MEDICAL OUTSOURCING LLC | 2 | 2017–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MILLSTONE MEDICAL OUTSOURCING LLC. | 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
Devices listed with FDA
What Millstone Medical Outsourcing LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Dental Implant SystemPrimaConnex Dental Implant SystemPrimaSolo Dental Implant SystemRENOVA Dental Implant SystemRESTORE Dental Implant SystemSTAGE - 1 Dental Implant System | 2013 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | PrimaConnex Dental Implant SystemSTAGE-1 Dental Implant System | 2013 |
| Human Source Bone Grafting MaterialNUN · Class 2 | Bone grafts & membranes | Maker | RegenerOss | 2023 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | CONTROLLER, FOOT, HANDPIECE AND CORD | 2013 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | — | 2023 |
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 |
|---|---|---|
| Millstone Medical Outsourcing LLCFDA reg. 3010097171 | Olive Branch, MS, United States | Contract manufacturer |
| MILLSTONE MEDICAL OUTSOURCING LLC.FDA reg. 1226544 | FALL RIVER, MA, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9042927). 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.