Clearance Summary
YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY received FDA 510(k) clearance under submission number K931717, sponsored by Kaycor Intl., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-09-20.
- Submission: K931717
- Applicant / Sponsor: Kaycor Intl., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1810
- Decision date: 1993-09-20
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.