Clearance Summary
TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS received FDA 510(k) clearance under submission number K140491, sponsored by Tanaka Dental. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-05-20.
- Submission: K140491
- Applicant / Sponsor: Tanaka Dental
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2015-05-20
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.