The following data is part of a premarket notification filed by Dentalpoint Ag with the FDA for Zeramex P6 Dental Implant System.
| Device ID | K152385 |
| 510k Number | K152385 |
| Device Name: | Zeramex P6 Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTALPOINT AG Hohlstrasse 614 Zurich, CH 8048 |
| Contact | Viktor Lienhard |
| Correspondent | Roshana Ahmed Mapi USA, Inc. 2343 Alexandria Drive Suite 100 Lexington, KY 40504 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-24 |
| Decision Date | 2016-07-27 |
| Summary: | summary |