Data / Medical devices / Spain / Gmi Dental Implantology, S.L.
Gmi Dental Implantology, S.L.: FDA-registered device maker in Lleida Lerida, Spain, 1 510(k) clearance
Gmi Dental Implantology, S.L. is registered with the FDA (registration 3009847764) in Lleida Lerida, Spain. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 19, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009847764
- Address
- Pol. Ind. "El Segre" C/ Enginyer Mies 705-B, Lleida Lerida, Spain, 25191
- Owner or operator
- GMI DENTAL IMPLANTOLOGY, S.L. (10054115)
- Roles
- Manufacturer
- First device listed
- February 13, 2017
- Registered through
- 2026
- Brand names listed
- Dental drills, Dental drills kits., GMI Frontier dental implant system, Instrumental, Instrumental kit., Prosthetic kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 19, 2017 | K161593 | GMI Frontier Dental Implant System | DZE | Substantially Equivalent | Ilerimplant S.L | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
Updated January 19, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.