Clearance Summary
DMD DIGITAL X-RAY SYSTEM received FDA 510(k) clearance under submission number K990087, sponsored by Dental/Medical Diagnostic 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 1999-05-13.
- Submission: K990087
- Applicant / Sponsor: Dental/Medical Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 1999-05-13
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.