Clearance Summary
BlueCheck Caries Detection & Monitoring received FDA 510(k) clearance under submission number K222560, sponsored by Incisive Technologies Pty, 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 2023-05-16.
- Submission: K222560
- Applicant / Sponsor: Incisive Technologies Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1740
- Decision date: 2023-05-16
Classification & Regulation
This clearance is catalogued under FDA product code LFC and 21 CFR 872.1740, within the Dental review panel as a Class II device.