Clearance Summary
A-Silicone for Bite Registration received FDA 510(k) clearance under submission number K201684, sponsored by Shandong Huge Dental Material Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-09-24.
- Submission: K201684
- Applicant / Sponsor: Shandong Huge Dental Material Corporation
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2020-09-24
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.