Clearance Summary
PORTABLE HDX INTRAORAL X-RAY received FDA 510(k) clearance under submission number K021378, sponsored by Dentalez Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-06-07.
- Submission: K021378
- Applicant / Sponsor: Dentalez Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2002-06-07
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.