The following data is part of a premarket notification filed by Trinon Titanium Gmbh with the FDA for Qza And Rs Dental Implant Systems.
Device ID | K163640 |
510k Number | K163640 |
Device Name: | QZA And RS Dental Implant Systems |
Classification | Implant, Endosseous, Root-form |
Applicant | TRINON Titanium GmbH Augartenstr. 1 Karlsruhe, DE 76137 |
Contact | Katja Lvova |
Correspondent | Katja Lvova TRINON Titanium GmbH Augartenstr. 1 Karlsruhe, DE 76137 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-23 |
Decision Date | 2017-05-03 |
Summary: | summary |