Data / Medical devices / Spain / Avinent Implant System S.L.U.
Avinent Implant System S.L.U.: FDA-registered device maker in Santpedor Barcelona, Spain, 4 510(k) clearances
Avinent Implant System S.L.U. is registered with the FDA (registration 3008791019) in Santpedor Barcelona, Spain. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 1, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008791019
- Address
- Ctra. de Navarcles,107. Pol. Ind. santa Anna I., Santpedor Barcelona, Spain, 08251
- Owner or operator
- Avinent Implant System S.L.U. (10046021)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 24, 2014
- Registered through
- 2026
- Brand names listed
- AVINENT IMPLANT SYSTEM, AVINENT IMPLANT SYSTEM S.L.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 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 |
|---|---|---|---|---|---|---|
| March 1, 2021 | K201533 | Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes | KCT | Substantially Equivalent | Avinent Implant System S.L.U. | accessdata.fda.gov |
| March 6, 2020 | K191566 | Avinent Surgical Tray | KCT | Substantially Equivalent | Avinent Implant System S.L.U. | accessdata.fda.gov |
| December 11, 2013 | K121873 | AVINENT DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Avinent Implant System S.L. | accessdata.fda.gov |
| October 24, 2013 | K122295 | CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS | NHA | Substantially Equivalent | Core 3D Protech, 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 Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Accessories, Implant, Dental, Endosseous
Updated March 1, 2021. 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.