The following data is part of a premarket notification filed by Z-systems Ag with the FDA for Z5c.
| Device ID | K132881 |
| 510k Number | K132881 |
| Device Name: | Z5C |
| 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 | 2013-09-13 |
| Decision Date | 2014-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640166760498 | K132881 | 000 |
| 07640166760412 | K132881 | 000 |
| 07640166760429 | K132881 | 000 |
| 07640166760436 | K132881 | 000 |
| 07640166760443 | K132881 | 000 |
| 07640166760450 | K132881 | 000 |
| 07640166760467 | K132881 | 000 |
| 07640166760474 | K132881 | 000 |
| 07640166760481 | K132881 | 000 |
| 07640166760405 | K132881 | 000 |