The following data is part of a premarket notification filed by Altatec Gmbh with the FDA for Abutment For Bridges.
Device ID | K153779 |
510k Number | K153779 |
Device Name: | Abutment For Bridges |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | ALTATEC GmbH Maybachstrasse 5 Wimsheim, DE D-71299 |
Contact | Colleen Boswell |
Correspondent | Linda 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 | 2015-12-31 |
Decision Date | 2016-03-31 |