S.I.N. Implant System Ltda
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0017-2026 | Class II | IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM | July 30, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | November 7, 2025 |
| K252266 | S.I.N. Dental Implant System | October 17, 2025 |
| K251262 | S.I.N. Dental Implant System | September 26, 2025 |
| K251046 | S.I.N. Dental Implant System | August 13, 2025 |