Clearance Summary
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 received FDA 510(k) clearance under submission number K032341, sponsored by Sota Precision Optics, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-08-25.
- Submission: K032341
- Applicant / Sponsor: Sota Precision Optics, Inc.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2003-08-25
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.