Clearance Summary
Reflect Implant System received FDA 510(k) clearance under submission number K180924, sponsored by Ids - Integrated Dental Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-03-29.
- Submission: K180924
- Applicant / Sponsor: Ids - Integrated Dental Systems
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2019-03-29
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.