The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Biodenta Customized Abutment - Titanium.
| Device ID | K151295 |
| 510k Number | K151295 |
| Device Name: | Biodenta Customized Abutment - Titanium |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, CH 9442 |
| Contact | David Elier |
| Correspondent | David Elier 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 | 2015-05-15 |
| Decision Date | 2015-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640169731747 | K151295 | 000 |
| 07640169731877 | K151295 | 000 |
| 07640169731891 | K151295 | 000 |
| 07640169731914 | K151295 | 000 |
| 07640169731921 | K151295 | 000 |
| 07640169731938 | K151295 | 000 |
| 07640169731945 | K151295 | 000 |
| 07640169731952 | K151295 | 000 |
| 07640169731969 | K151295 | 000 |
| 07640169731860 | K151295 | 000 |
| 07640169731853 | K151295 | 000 |
| 07640169731846 | K151295 | 000 |
| 07640169731754 | K151295 | 000 |
| 07640169731761 | K151295 | 000 |
| 07640169731778 | K151295 | 000 |
| 07640169731792 | K151295 | 000 |
| 07640169731808 | K151295 | 000 |
| 07640169731815 | K151295 | 000 |
| 07640169731822 | K151295 | 000 |
| 07640169731839 | K151295 | 000 |
| 07640169731976 | K151295 | 000 |
| 07640169731983 | K151295 | 000 |
| 07640169731990 | K151295 | 000 |
| 07640169732140 | K151295 | 000 |
| 07640169732157 | K151295 | 000 |
| 07640169732218 | K151295 | 000 |
| 07640169732225 | K151295 | 000 |
| 07640169732287 | K151295 | 000 |
| 07640169732300 | K151295 | 000 |
| 07640169732317 | K151295 | 000 |
| 07640169732331 | K151295 | 000 |
| 07640169732119 | K151295 | 000 |
| 07640169732102 | K151295 | 000 |
| 07640169732096 | K151295 | 000 |
| 07640169732003 | K151295 | 000 |
| 07640169732010 | K151295 | 000 |
| 07640169732027 | K151295 | 000 |
| 07640169732034 | K151295 | 000 |
| 07640169732041 | K151295 | 000 |
| 07640169732058 | K151295 | 000 |
| 07640169732072 | K151295 | 000 |
| 07640169732089 | K151295 | 000 |
| 07640169739910 | K151295 | 000 |