Calabasas, CA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | 3 | 2025-12-23 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General Hospital | 1 | 2025-11-14 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-23 | K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | DZE | Class II | Dental |
| 2025-12-23 | K250476 | NizPlant Dental Implant System | DZE | Class II | Dental |
| 2025-11-14 | K251756 | Sterilization Trays | KCT | Class II | General Hospital |
| 2025-10-30 | K251938 | GEN5 and GEN5+ Dental Implant System | DZE | Class II | Dental |