Clearance Summary
MEDIADENT HDX/MMD HDX SP XRAY SENSOR received FDA 510(k) clearance under submission number K002425, sponsored by Multi Media Dental Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-12-21.
- Submission: K002425
- Applicant / Sponsor: Multi Media Dental Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2000-12-21
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.