Clearance Summary
YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA received FDA 510(k) clearance under submission number K000577, sponsored by The Yoshida Dental Mfg. Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-05-05.
- Submission: K000577
- Applicant / Sponsor: The Yoshida Dental Mfg. Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2000-05-05
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.