Clearance Summary
MODEL 410 DENTAL X-RAY FILM PROCESSORS received FDA 510(k) clearance under submission number K874118, sponsored by Dent-X Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1987-11-06.
- Submission: K874118
- Applicant / Sponsor: Dent-X Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1987-11-06
Classification & Regulation
This clearance is catalogued under FDA product code EGY and 21 CFR 892.1900, within the Radiology review panel as a Class II device.