Clearance Summary
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED received FDA 510(k) clearance under submission number K973541, sponsored by Medental Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-11-25.
- Submission: K973541
- Applicant / Sponsor: Medental Intl.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 1997-11-25
Classification & Regulation
This clearance is catalogued under FDA product code EBC and 21 CFR 872.3765, within the Dental review panel as a Class II device.