Clearance Summary
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite received FDA 510(k) clearance under submission number K181604, sponsored by Hrs Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-11-28.
- Submission: K181604
- Applicant / Sponsor: Hrs Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2018-11-28
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.