The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Biodenta Customized Abutment-hybrid.
| Device ID | K150296 |
| 510k Number | K150296 |
| Device Name: | Biodenta Customized Abutment-Hybrid |
| 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 | 2015-02-06 |
| Decision Date | 2015-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640169739927 | K150296 | 000 |
| 07640169734878 | K150296 | 000 |
| 07640169734885 | K150296 | 000 |
| 07640169734915 | K150296 | 000 |
| 07640169734922 | K150296 | 000 |
| 07640169734946 | K150296 | 000 |
| 07640169734960 | K150296 | 000 |
| 07640169734977 | K150296 | 000 |
| 07640169734984 | K150296 | 000 |
| 07640169734991 | K150296 | 000 |
| 07640169735004 | K150296 | 000 |
| 07640169735042 | K150296 | 000 |
| 07640169735059 | K150296 | 000 |
| 07640169735066 | K150296 | 000 |
| 07640169735073 | K150296 | 000 |
| 07640169735080 | K150296 | 000 |
| 07640169735097 | K150296 | 000 |
| 07640169734847 | K150296 | 000 |