The following data is part of a premarket notification filed by Altatec Gmbh with the FDA for Cam Titanium Blanks.
| Device ID | K160784 |
| 510k Number | K160784 |
| Device Name: | CAM Titanium Blanks |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ALTATEC GMBH MAYBACHSTRASSE 5 Wimsheim, DE D-71299 |
| Contact | Colleen Boswell |
| 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 | 2016-03-22 |
| Decision Date | 2016-09-14 |
| Summary: | summary |