The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Biodenta Dental Implant System- Bone Level D 3.0 To 6.0 Mm.
| Device ID | K123512 |
| 510k Number | K123512 |
| Device Name: | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM |
| 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 | 2012-11-13 |
| Decision Date | 2013-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640169733963 | K123512 | 000 |
| 07640169732379 | K123512 | 000 |
| 07640169732362 | K123512 | 000 |
| 07640169732355 | K123512 | 000 |
| 07640169731174 | K123512 | 000 |
| 07640169731105 | K123512 | 000 |
| 07640169731099 | K123512 | 000 |
| 07640169730986 | K123512 | 000 |
| 07640169730979 | K123512 | 000 |
| 07640169730207 | K123512 | 000 |
| 07640169730030 | K123512 | 000 |
| 07640169730023 | K123512 | 000 |
| 07640169732423 | K123512 | 000 |
| 07640169732478 | K123512 | 000 |
| 07640169733956 | K123512 | 000 |
| 07640169733949 | K123512 | 000 |
| 07640169733871 | K123512 | 000 |
| 07640169733864 | K123512 | 000 |
| 07640169733857 | K123512 | 000 |
| 07640169733727 | K123512 | 000 |
| 07640169733697 | K123512 | 000 |
| 07640169732553 | K123512 | 000 |
| 07640169732546 | K123512 | 000 |
| 07640169732539 | K123512 | 000 |
| 07640169732522 | K123512 | 000 |
| 07640169730016 | K123512 | 000 |