Clearance Summary
Z5-BL received FDA 510(k) clearance under submission number K190243, sponsored by Z-Systems AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-01-03.
- Submission: K190243
- Applicant / Sponsor: Z-Systems AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2020-01-03
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.