Kloten, CH · 5 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General Hospital | 2 | 2023-06-27 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | 2 | 2022-09-16 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | 1 | 2021-12-21 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-07-20 | Class II | Terminated | Z-2828-2020 | NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in th… | — | Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placem… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-06-27 | K231219 | NobelZygoma PureSet Tray | KCT | Class II | General Hospital |
| 2022-09-16 | K220339 | Esthetic Abutments Nobel Biocare N1 | NHA | Class II | Dental |
| 2022-07-29 | K220048 | NobelProcera Zirconia N1 Base | NHA | Class II | Dental |
| 2021-12-21 | K211109 | N1 TiUltra TCC Implant System | DZE | Class II | Dental |
| 2021-12-18 | K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray | KCT | Class II | General Hospital |