Clearance Summary
TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS received FDA 510(k) clearance under submission number K071010, sponsored by Schutz-Dental GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-08-24.
- Submission: K071010
- Applicant / Sponsor: Schutz-Dental GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2007-08-24
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.