The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Biodenta Customized Abutment.
| Device ID | K110778 |
| 510k Number | K110778 |
| Device Name: | BIODENTA CUSTOMIZED ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, CH 9442 |
| Contact | Angela Blackwell |
| Correspondent | Angela Blackwell 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 | 2011-03-21 |
| Decision Date | 2011-07-29 |
| Summary: | summary |