Data / Medical devices / Spain / Ceraroot S.L.
Ceraroot S.L.: FDA-registered device maker in Les Franqueses del Valles Barcelona, Spain, 1 510(k) clearance
Ceraroot S.L. is registered with the FDA (registration 3008808095) in Les Franqueses del Valles Barcelona, Spain. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 4, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008808095
- Address
- Parpers 13, Les Franqueses del Valles Barcelona, Spain, 08520
- Owner or operator
- CERAROOT S.L. (10034855)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- January 10, 2011
- Registered through
- 2026
- Brand names listed
- Bur extension -steel (AIP-3), CeraRoot, CeraRoot Guided Surgery System (02002S), CeraRoot ceramic implant, CeraRoot surgical kit, CeraRoot zirconium oxide dental implant, Ceramic Tray (02004), Contra Angle Driver 4x4 (ACE-8) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 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 4, 2011 | K093595 | CERAROOT IMPLANT SYSTEM | DZE | Substantially Equivalent | Oral Iceberg S.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Crown, Preformed
- All makers of Implant, Endosseous, Root-Form
Updated January 4, 2011. 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.