The following data is part of a premarket notification filed by Sds Swiss Dental Solutions Ag with the FDA for Sds2.2 Dental Implant.
| Device ID | K190406 |
| 510k Number | K190406 |
| Device Name: | SDS2.2 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 | 2019-02-21 |
| Decision Date | 2020-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260468255817 | K190406 | 000 |
| 04260468251321 | K190406 | 000 |
| 04260468251314 | K190406 | 000 |
| 04260468251307 | K190406 | 000 |
| 04260468251291 | K190406 | 000 |
| 04260468251284 | K190406 | 000 |
| 04260468250676 | K190406 | 000 |
| 04260468250669 | K190406 | 000 |
| 04260468250652 | K190406 | 000 |
| 04260468251338 | K190406 | 000 |
| 04260468251345 | K190406 | 000 |
| 04260468251352 | K190406 | 000 |
| 04260468255800 | K190406 | 000 |
| 04260468255794 | K190406 | 000 |
| 04260468255787 | K190406 | 000 |
| 04260468255558 | K190406 | 000 |
| 04260468251512 | K190406 | 000 |
| 04260468251505 | K190406 | 000 |
| 04260468251499 | K190406 | 000 |
| 04260468251482 | K190406 | 000 |
| 04260468250256 | K190406 | 000 |