Clearance Summary
Ceramic Denture Zirconia Ceramics Block received FDA 510(k) clearance under submission number K181816, sponsored by Qinhuangdao Silide Ceramic Technology 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 2018-11-29.
- Submission: K181816
- Applicant / Sponsor: Qinhuangdao Silide Ceramic Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2018-11-29
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.