Clearance Summary
S.I.N. Dental Implant System received FDA 510(k) clearance under submission number K211921, sponsored by S.I.N. - Sistema DE Implante Nacional S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-10-20.
- Submission: K211921
- Applicant / Sponsor: S.I.N. - Sistema DE Implante Nacional S.A.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2021-10-20
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.