Manufacturer registered with FDA
Nextmed srls
Milan, Italy. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Italy
Registered in 2 markets
Where regulators' registries name Nextmed srls 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 | Nextmed srls | 1 device types | — | Below |
| Brazil | ANVISA | Manufacturer | ADVANCED TECHNOLOGY RESEARCH | 1 | 2009–2009 | 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 Nextmed srls currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | EnDrive | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Nextmed srls lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Advanced Technology Research (A.T.R.) S.R.L. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Aug 2025 | K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | EKX Ac-Powered Direct Drive Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ADVANCED TECHNOLOGY RESEARCH S.R.L.FDA reg. 9614866 | PISTOIA, Italy | Manufacturer |
Other names on FDA records
Advanced Technology Research
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083727). 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.