Clearance Summary
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance under submission number K160367, sponsored by Nissin-Metec China 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 2016-07-27.
- Submission: K160367
- Applicant / Sponsor: Nissin-Metec China Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2016-07-27
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.