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 D3.0 And L6.5mm.
| Device ID | K133884 |
| 510k Number | K133884 |
| Device Name: | BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640169731624 | K133884 | 000 |
| 07640169731570 | K133884 | 000 |
| 07640169731525 | K133884 | 000 |
| 07640169731471 | K133884 | 000 |
| 07640169731464 | K133884 | 000 |
| 07640169731457 | K133884 | 000 |