The following data is part of a premarket notification filed by Z-systems Ag with the FDA for Z5-bl.
| Device ID | K190243 |
| 510k Number | K190243 |
| Device Name: | Z5-BL |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Z-Systems AG Werkhofstrasse 5 Oensingen, CH 4702 |
| Contact | Rubino Digirolamo |
| Correspondent | Kevin A. Thomas 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 | 2019-02-06 |
| Decision Date | 2020-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640166760856 | K190243 | 000 |
| 07640166760849 | K190243 | 000 |
| 07640166760832 | K190243 | 000 |
| 07640166760825 | K190243 | 000 |
| 07640166760818 | K190243 | 000 |
| 07640166760801 | K190243 | 000 |
| 07640166760863 | K190243 | 000 |
| 07640166764700 | K190243 | 000 |
| 07640166760870 | K190243 | 000 |