Clearance Summary
CS 8100 CS 8100 ACCESS received FDA 510(k) clearance under submission number K120975, sponsored by Trophy. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-06-22.
- Submission: K120975
- Applicant / Sponsor: Trophy
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2012-06-22
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.