Clearance Summary
W Zirconia Implants received FDA 510(k) clearance under submission number K192053, sponsored by Tav Medical , 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 2019-10-29.
- Submission: K192053
- Applicant / Sponsor: Tav Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2019-10-29
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.