Clearance Summary
ROS-TR SYSTEM received FDA 510(k) clearance under submission number K884140, sponsored by Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-03-13.
- Submission: K884140
- Applicant / Sponsor: Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1989-03-13
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.