Manufacturer registered with FDA
Avinent Implant System S.L.U.
Santpedor, Spain. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 22013–2026
- Markets registered in
- 799 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Avinent Implant System S.L.U. 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 | Avinent Implant System S.L.U. | 2 clearances | 2013–2026 | Below |
| Canada | Health Canada | Registration holder | AVINENT IMPLANT SYSTEM S.L.U. | 60 | 2012–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | AVINENT IMPLANT SYSTEM S.L.UAVINENT IMPLANT SYSTEM S.L.U. · AVINENT IMPLANT SYSTEM S.L. | 13 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | AVINENT IMPLANT SYSTEM, S.L.U. | 13 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | AVINENT IMPLANT, SYSTEM, S.L.U.AVINENT IMPLANT SYSTEM S.L. · AVINENT IMPLANT SYSTEM S.L.U. · +1 | 8 | 2008–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Avinent Implant System SLU | 3 | 2018–2018 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | AVINENT IMPLANT SYSTEM S.L.U. | 2 | — | 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 Avinent Implant System S.L.U. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | AVINENT IMPLANT SYSTEMAVINENT IMPLANT SYSTEM S.L. | 2014 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | AVINENT IMPLANT SYSTEM | 2014 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | AVINENT IMPLANT SYSTEM | 2014 |
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
Avinent Implant System S.L.U. 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: Core 3D Protech, S.L. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Oct 2013 | K122295 | CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS | Core 3D Protech, S.L. | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AVINENT IMPLANT SYSTEM S.L.U.FDA reg. 3008791019 | Santpedor Barcelona, Spain | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046021). 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.