The following data is part of a premarket notification filed by Z-systems Ag with the FDA for Z5mlb, Z5mlc.
| Device ID | K131701 |
| 510k Number | K131701 |
| Device Name: | Z5MLB, Z5MLC |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Z-Systems AG 12264 EL CAMINO REAL STE. 400 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz Z-Systems AG 12264 EL CAMINO REAL STE. 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 | 2013-06-11 |
| Decision Date | 2013-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640166760351 | K131701 | 000 |
| 07640166760344 | K131701 | 000 |
| 07640166760337 | K131701 | 000 |
| 07640166760313 | K131701 | 000 |
| 07640166760306 | K131701 | 000 |
| 07640166760238 | K131701 | 000 |
| 07640166760221 | K131701 | 000 |
| 07640166760214 | K131701 | 000 |
| 07640166760207 | K131701 | 000 |