The following data is part of a premarket notification filed by Z-systems Ag with the FDA for Z-look3 Dental Implant System, Model Z3-xxx.
| Device ID | K062542 |
| 510k Number | K062542 |
| Device Name: | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Z-Systems AG 11234 EL CAMINO REAL STE: 200 San Diego, CA 92024 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson Z-Systems AG 11234 EL CAMINO REAL STE: 200 San Diego, CA 92024 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2007-10-29 |
| Summary: | summary |