Clearance Summary
DIFOTI SYSTEM received FDA 510(k) clearance under submission number K991098, 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 1999-06-30.
- Submission: K991098
- Applicant / Sponsor: Electro-Optical Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1999-06-30
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.