The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Biodenta Dental Implant System- Bone Level Tapered.
| Device ID | K123415 |
| 510k Number | K123415 |
| Device Name: | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, St.gallen, CH 9442 |
| Contact | David Eiler |
| Correspondent | David Eiler BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, St.gallen, 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 | 2012-11-05 |
| Decision Date | 2013-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640169731655 | K123415 | 000 |
| 07640169731495 | K123415 | 000 |
| 07640169731501 | K123415 | 000 |
| 07640169731518 | K123415 | 000 |
| 07640169731532 | K123415 | 000 |
| 07640169731549 | K123415 | 000 |
| 07640169731556 | K123415 | 000 |
| 07640169731563 | K123415 | 000 |
| 07640169731587 | K123415 | 000 |
| 07640169731594 | K123415 | 000 |
| 07640169731600 | K123415 | 000 |
| 07640169731617 | K123415 | 000 |
| 07640169731631 | K123415 | 000 |
| 07640169731648 | K123415 | 000 |
| 07640169731488 | K123415 | 000 |