Clearance Summary
CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES received FDA 510(k) clearance under submission number K061175, sponsored by Sota Precision Optics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-05-23.
- Submission: K061175
- Applicant / Sponsor: Sota Precision Optics, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2006-05-23
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.