Clearance Summary
INTREX INTERORAL DENTAL X-RAY UNIT received FDA 510(k) clearance under submission number K930925, sponsored by Keystone X-Ray, 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 1993-07-13.
- Submission: K930925
- Applicant / Sponsor: Keystone X-Ray, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1810
- Decision date: 1993-07-13
Classification & Regulation
This clearance is catalogued under FDA product code EAP and 21 CFR 872.1810, within the Dental review panel as a Class II device.