Clearance Summary
QZA and RS Dental Implant Systems received FDA 510(k) clearance under submission number K163640, sponsored by Trinon Titanium GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-05-03.
- Submission: K163640
- Applicant / Sponsor: Trinon Titanium GmbH
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2017-05-03
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.