Data / Medical devices / Switzerland / SDS Swiss Dental Solutions
SDS Swiss Dental Solutions: FDA-registered device maker in Kreuzlingen Thurgau, Switzerland, 2 510(k) clearances
SDS Swiss Dental Solutions is registered with the FDA (registration 3014540272) in Kreuzlingen Thurgau, Switzerland. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 20, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014540272
- Address
- SDS Swiss Dental Solutions AG Konstanzerstrasse 11, Kreuzlingen Thurgau, Switzerland, 8280
- Owner or operator
- SDS Swiss Dental Solutions AG (10057971)
- Roles
- Specification developer
- First device listed
- June 20, 2018
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Specification developer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Specification developer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 20, 2020 | K190406 | SDS2.2 dental implant | DZE | Substantially Equivalent | Sds Swiss Dental Solutions AG | accessdata.fda.gov |
| November 20, 2019 | K181953 | SDS1.2 dental implant | DZE | Substantially Equivalent | Sds Swiss Dental Solutions AG | accessdata.fda.gov |
Compare with other makers
- All makers of Gauge, Depth, Instrument, Dental
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Bur, Dental
- All makers of Accessories, Implant, Dental, Endosseous
Updated February 20, 2020. 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.