Clearance Summary
SEPTOSIL SILICONE FOR PRECISION IMPRESSION received FDA 510(k) clearance under submission number K851388, sponsored by Specialites Septodont. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1985-05-29.
- Submission: K851388
- Applicant / Sponsor: Specialites Septodont
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1985-05-29
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.