Clearance Summary
CERALOY received FDA 510(k) clearance under submission number K021971, sponsored by Neirynck & Vogt NV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-08-01.
- Submission: K021971
- Applicant / Sponsor: Neirynck & Vogt NV
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 2002-08-01
Classification & Regulation
This clearance is catalogued under FDA product code EJH and 21 CFR 872.3710, within the Dental review panel as a Class II device.