The following data is part of a premarket notification filed by Trinon Titanium Gmbh with the FDA for Trinon Q & Q3 Implant System.
| Device ID | K103577 |
| 510k Number | K103577 |
| Device Name: | TRINON Q & Q3 IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | TRINON TITANIUM GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, DE 78576 |
| Contact | Markus Denk |
| Correspondent | Markus Denk TRINON TITANIUM GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, DE 78576 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2012-07-03 |
| Summary: | summary |