The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Biodenta Dental Implant System - Multi-use Abutment.
| Device ID | K123491 |
| 510k Number | K123491 |
| Device Name: | BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-05-30 |
| Summary: | summary |