Clearance Summary
DIFOTI USB 2.0 SYSTEM received FDA 510(k) clearance under submission number K043068, sponsored by Electro-Optical Sciences, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-12-29.
- Submission: K043068
- Applicant / Sponsor: Electro-Optical Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1745
- Decision date: 2004-12-29
Classification & Regulation
This clearance is catalogued under FDA product code NTK and 21 CFR 872.1745, within the Dental review panel as a Class II device.