The following data is part of a premarket notification filed by Sds Swiss Dental Solutions Ag with the FDA for Sds1.2 Dental Implant.
| Device ID | K181953 |
| 510k Number | K181953 |
| Device Name: | SDS1.2 Dental Implant |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SDS Swiss Dental Solutions AG Konstanzerstrasse 11 Kreuzlingen, CH 8280 |
| Contact | Martin Chares |
| Correspondent | Martin Chares SDS Swiss Dental Solutions AG Konstanzerstrasse 11 Kreuzlingen, CH 8280 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-23 |
| Decision Date | 2019-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260468255374 | K181953 | 000 |
| 04260468251246 | K181953 | 000 |
| 04260468251239 | K181953 | 000 |
| 04260468251222 | K181953 | 000 |
| 04260468251215 | K181953 | 000 |
| 04260468251208 | K181953 | 000 |
| 04260468251192 | K181953 | 000 |
| 04260468250645 | K181953 | 000 |
| 04260468250508 | K181953 | 000 |
| 04260468250171 | K181953 | 000 |
| 04260468251253 | K181953 | 000 |
| 04260468251260 | K181953 | 000 |
| 04260468255367 | K181953 | 000 |
| 04260468254285 | K181953 | 000 |
| 04260468254223 | K181953 | 000 |
| 04260468251895 | K181953 | 000 |
| 04260468251413 | K181953 | 000 |
| 04260468251406 | K181953 | 000 |
| 04260468251390 | K181953 | 000 |
| 04260468251383 | K181953 | 000 |
| 04260468251277 | K181953 | 000 |
| 04260468250164 | K181953 | 000 |