The following data is part of a premarket notification filed by Z-systems Ag with the FDA for Z5m(t).
| Device ID | K150021 |
| 510k Number | K150021 |
| Device Name: | Z5m(t) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Z-Systems AG Bittertenstrasse 15 Oensingen, CH 4702 |
| Contact | Thomas Hug |
| Correspondent | Linda K. Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-06 |
| Decision Date | 2015-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640166760559 | K150021 | 000 |
| 07640166760542 | K150021 | 000 |
| 07640166760535 | K150021 | 000 |
| 07640166760528 | K150021 | 000 |
| 07640166760511 | K150021 | 000 |
| 07640166760504 | K150021 | 000 |