Clearance Summary
PORTABLE DENTAL X-RAY UNIT MODEL 4000 received FDA 510(k) clearance under submission number K872240, sponsored by Home/Office Dental, 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 1987-07-16.
- Submission: K872240
- Applicant / Sponsor: Home/Office Dental, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 1987-07-16
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.