Clearance Summary
SEE-IT CARIES DETECTOR received FDA 510(k) clearance under submission number K060330, sponsored by Ronvig Dental Mfg. A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-04-07.
- Submission: K060330
- Applicant / Sponsor: Ronvig Dental Mfg. A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1740
- Decision date: 2006-04-07
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.