The following data is part of a premarket notification filed by Dentalpoint Ag with the FDA for Zeramex(r) Xt Dental Implant System, Nobelpearl Dental Implant System.
| Device ID | K180184 |
| 510k Number | K180184 |
| Device Name: | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Dentalpoint AG Bodenackerstrasse 5 Spreitenbach, CH 8957 |
| Contact | Anja Lieberherr |
| Correspondent | Elizabeth Rose Mapi USA, Inc. 2343 Alexandria Dirve Suite 100 Lexington, KY 40504 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-23 |
| Decision Date | 2018-11-16 |
| Summary: | summary |