Data / Medical devices / Switzerland / CeramTec Schweiz GmbH
CeramTec Schweiz GmbH: FDA-registered device maker in Spreitenbach Aargau, Switzerland, 3 510(k) clearances
CeramTec Schweiz GmbH is registered with the FDA (registration 3008388248) in Spreitenbach Aargau, Switzerland. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 16, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008388248
- Address
- Bodenaeckerstrasse 5, Spreitenbach Aargau, Switzerland, 8957
- Owner or operator
- CeramTec Schweiz GmbH (10032409)
- Roles
- Manufacturer
- First device listed
- August 6, 2010
- Registered through
- 2026
- Brand names listed
- Zeramex Dental Implant System
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 |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Dental Tray | OFX | 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 |
|---|---|---|---|---|---|---|
| November 16, 2018 | K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | NHA | Substantially Equivalent | Dentalpoint AG | accessdata.fda.gov |
| November 30, 2016 | K163043 | Zeramex P6 Dental Implant System | DZE | Substantially Equivalent | Dentalpoint AG | accessdata.fda.gov |
| July 27, 2016 | K152385 | Zeramex P6 Dental Implant System | DZE | Substantially Equivalent | Dentalpoint AG | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Bur, Dental
- All makers of General Purpose Dental Tray
Updated November 16, 2018. 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.