The following data is part of a premarket notification filed by Altatec Gmbh with the FDA for Conelog Titanium Base Cad/cam.
Device ID | K143337 |
510k Number | K143337 |
Device Name: | CONELOG Titanium Base CAD/CAM |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | ALTATEC GMBH Maybachstrasse 5 Wimsheim, DE D-71299 |
Contact | Dennis Pappas |
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 | 2014-11-20 |
Decision Date | 2015-02-17 |
Summary: | summary |