Clearance Summary
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio received FDA 510(k) clearance under submission number K143753, sponsored by Rayence Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-03-10.
- Submission: K143753
- Applicant / Sponsor: Rayence Co., Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2015-03-10
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.