Thousand Oaks, CA, US · 9 510(k) clearances · 4 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | 3 | 2023-02-02 |
| DZI | Drill, Bone, Powered | Class II | Dental | 2 | 2023-08-16 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | 2 | 2023-06-20 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General Hospital | 2 | 2021-01-28 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-05-01 | Class II | Ongoing | Z-2172-2025 | The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop leng… | — | The Drill stop kit contains incorrect components. |
| 2023-05-02 | Class II | Ongoing | Z-2037-2023 | LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW… | — | Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. |
| 2021-09-23 | Class II | Ongoing | Z-0198-2022 | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, | — | Packaged dental implant contains a different size then the size declared on the labeling. |
| 2021-09-23 | Class II | Ongoing | Z-0197-2022 | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | — | Packaged dental implant contains a different size then the size declared on the labeling. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-08-16 | K231087 | Guided Surgery Kit | DZI | Class II | Dental |
| 2023-06-20 | K223535 | SMARTbase Abutment System | NHA | Class II | Dental |
| 2023-02-02 | K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional | DZE | Class II | Dental |
| 2021-01-28 | K202524 | Standard Sterilizable Tray | KCT | Class II | General Hospital |
| 2021-01-22 | K201553 | Simply Iconic Implants | DZE | Class II | Dental |
| 2020-08-06 | K200858 | Mini Sterilizable Tray | KCT | Class II | General Hospital |
| 2020-06-30 | K200265 | Surgical Drills | DZI | Class II | Dental |
| 2020-06-25 | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts | DZE | Class II | Dental |
| 2020-05-08 | K192218 | Custom Legacy and Custom InterActive Titanium Abutments | NHA | Class II | Dental |