The following data is part of a premarket notification filed by Dentalpoint Ag with the FDA for Zeramex P6 Dental Implant System.
| Device ID | K163043 |
| 510k Number | K163043 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2016-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640161396685 | K163043 | 000 |
| 07640161396531 | K163043 | 000 |
| 07640161396524 | K163043 | 000 |
| 07640161396517 | K163043 | 000 |
| 07640161396500 | K163043 | 000 |
| 07640161396494 | K163043 | 000 |
| 07640161396487 | K163043 | 000 |
| 07640161396470 | K163043 | 000 |
| 07640161396463 | K163043 | 000 |
| 07640161396456 | K163043 | 000 |
| 07640161396449 | K163043 | 000 |
| 07640161396432 | K163043 | 000 |
| 07640161396548 | K163043 | 000 |
| 07640161396555 | K163043 | 000 |
| 07640161396562 | K163043 | 000 |
| 07640161396678 | K163043 | 000 |
| 07640161396661 | K163043 | 000 |
| 07640161396654 | K163043 | 000 |
| 07640161396647 | K163043 | 000 |
| 07640161396630 | K163043 | 000 |
| 07640161396623 | K163043 | 000 |
| 07640161396616 | K163043 | 000 |
| 07640161396609 | K163043 | 000 |
| 07640161396593 | K163043 | 000 |
| 07640161396586 | K163043 | 000 |
| 07640161396579 | K163043 | 000 |
| 07640161396401 | K163043 | 000 |