The following data is part of a premarket notification filed by Thommen Medical Ag with the FDA for Thommen Milling Abutment For Cad/cam.
| Device ID | K151984 |
| 510k Number | K151984 |
| Device Name: | Thommen Milling Abutment For CAD/CAM |
| 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 | 2015-07-17 |
| Decision Date | 2016-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640156478914 | K151984 | 000 |
| 07640156477474 | K151984 | 000 |
| 07640156477498 | K151984 | 000 |
| 07640156477528 | K151984 | 000 |
| 07640156477535 | K151984 | 000 |
| 07640156478860 | K151984 | 000 |
| 07640156478877 | K151984 | 000 |
| 07640156478884 | K151984 | 000 |
| 07640156478891 | K151984 | 000 |
| 07640156477429 | K151984 | 000 |