Clearance Summary
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance under submission number K180252, sponsored by Crown Porcelain Dental 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 2018-04-24.
- Submission: K180252
- Applicant / Sponsor: Crown Porcelain Dental Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2018-04-24
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.