Clearance Summary
KODAK MODELS 2100 AND 2200 received FDA 510(k) clearance under submission number K060292, sponsored by Kodak-Trophy. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-03-03.
- Submission: K060292
- Applicant / Sponsor: Kodak-Trophy
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2006-03-03
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.