Clearance Summary
SERENOCEM, MODEL BC 010 received FDA 510(k) clearance under submission number K003567, sponsored by Corinthian Medical , 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 2001-02-12.
- Submission: K003567
- Applicant / Sponsor: Corinthian Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2001-02-12
Classification & Regulation
This clearance is catalogued under FDA product code NEA and 21 CFR 872.3275, within the Dental review panel as a Class II device.