Clearance Summary
AIDITE ZIRCONIA DENTAL CERAMICS received FDA 510(k) clearance under submission number K111291, sponsored by Qinhuangdao Aidite High-Technical Ceramics 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 2011-07-20.
- Submission: K111291
- Applicant / Sponsor: Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2011-07-20
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.