Clearance Summary
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D received FDA 510(k) clearance under submission number K040691, sponsored by Win-Us Technology 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 2004-03-23.
- Submission: K040691
- Applicant / Sponsor: Win-Us Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2004-03-23
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.