Manufacturer registered with FDA
GMI Dental Implantology, S.L.
Barcelona, Spain. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 427 registrations outside the US
- Establishments
- 1Spain
Registered in 4 markets
Where regulators' registries name GMI Dental Implantology, S.L. 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 | GMI Dental Implantology, S.L. | 3 device types | — | Below |
| European Union | EUDAMED | Registration holder | GMI Dental Implantology, S.L. | 10 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GMI DENTAL IMPLANTOLOGY, S.L. | 9 | 2017–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | GMI DENTAL IMPLANTOLOGY, S.L., | 8 | — | 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 GMI Dental Implantology, S.L. 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 | GMI Frontier dental implant system | 2017 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental drillsDental drills kits.InstrumentalInstrumental kit.Prosthetic kit | 2021 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | GMI Frontier dental implant system | 2017 |
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
GMI Dental Implantology, S.L. 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: Ilerimplant S.L (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Jan 2017 | K161593 | GMI Frontier Dental Implant System | Ilerimplant S.L | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GMI DENTAL IMPLANTOLOGY, S.L.FDA reg. 3009847764 | Lleida Lerida, Spain | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054115). 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.