The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Biodenta Dental Implant System.
| Device ID | K093630 |
| 510k Number | K093630 |
| Device Name: | BIODENTA DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, CH 9442 |
| Contact | David Eiler |
| Correspondent | David Eiler BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, CH 9442 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-23 |
| Decision Date | 2010-06-03 |
| Summary: | summary |