SDS Swiss Dental Solutions AG
CH-MF-000019073 · Switzerland · Kreuzlingen
SDS Swiss Dental Solutions AG is registered in the European database on medical devices as a manufacturer, with 56 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 53 |
|---|---|
| Class IIb | 3 |
Most frequent device types declared: BISS Handschraubendreher, Countersink drills, Form drills, Initial drills, Insertion tools reusable.
Among these devices, 3 are declared sterile, 3 implantable, 27 reusable, 18 with a measuring function.
Authorised representative in the Union: SDS Deutschland GmbH.
Devices declared under this manufacturer
- BISS Schraubendreher Einsatz mittel
- BISS Schraubendreher Griff
- Countersink drill D3- Ø4.6
- Countersink drill D3- Ø5.4
- Form drill D1- Ø4.6
- Form drill D2- Ø5.4
- Form drill D4- Ø3.8
- Insertion tool SDS1.2 short
- Insertion tool SDS2.2 long
- Pilot drill
- SDS1.2 Insertion tool single-use
- SDS1.2, 3.8 mm temporary cap
Showing 12 of 56 declared devices.
Catalogue references include BISS_SDH, BISS_SDI-M, SDS1.2_PC_3.8-P, SDS2.0_CS-600, SDS2.2_ITscrew-ST, SDSpd250.
European nomenclature codes declared: Q010399, P01020180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SDS SWISS DENTAL SOLUTIONS (CH) · FDA 3014540272 |
| Devices in EUDAMED | 56 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 56 |
|---|---|
| Found in the U.S. device database | 36 |
| Share | 64.3 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. SDS Swiss Dental Solutions AG is registered in the United States but was not found in the Canadian register.