Clearance Summary
CHROMASCAN TM received FDA 510(k) clearance under submission number K770667, sponsored by Sterndent Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-04-20.
- Submission: K770667
- Applicant / Sponsor: Sterndent Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3661
- Decision date: 1977-04-20
Classification & Regulation
This clearance is catalogued under FDA product code KZN and 21 CFR 872.3661, within the Dental review panel as a Class II device.