The following data is part of a premarket notification filed by Thommen Medical Ag with the FDA for Variounite.
| Device ID | K160244 |
| 510k Number | K160244 |
| Device Name: | VARIOunite |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Thommen Medical AG Neckarsulmstrasse 28 Grenchen, CH 2540 |
| Contact | Daniel Snetivy |
| Correspondent | Linda K Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-06-02 |
| Summary: | summary |