S.I.N. Implant System Ltda

FDA Regulatory Profile

S.I.N. Implant System Ltda appears in FDA public data with 1 recall, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0017-2026, Class II) was initiated on July 30, 2025. Its most recent 510(k) clearance was granted on November 7, 2025.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0017-2026Class IIIMPLANT 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-NumberDeviceDate
K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemNovember 7, 2025
K252266S.I.N. Dental Implant SystemOctober 17, 2025
K251262S.I.N. Dental Implant SystemSeptember 26, 2025
K251046S.I.N. Dental Implant SystemAugust 13, 2025