São Paulo, BR · 4 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | 3 | 2025-11-07 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | 1 | 2025-10-17 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-07-30 | Class II | Ongoing | Z-0017-2026 | IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIK… | — | Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be pac… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-07 | K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | DZE | Class II | Dental |
| 2025-10-17 | K252266 | S.I.N. Dental Implant System | NHA | Class II | Dental |
| 2025-09-26 | K251262 | S.I.N. Dental Implant System | DZE | Class II | Dental |
| 2025-08-13 | K251046 | S.I.N. Dental Implant System | DZE | Class II | Dental |