Clearance Summary
INSTANT CURE-1 received FDA 510(k) clearance under submission number K780898, sponsored by Ultra-Light 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 1978-06-30.
- Submission: K780898
- Applicant / Sponsor: Ultra-Light Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 1978-06-30
Classification & Regulation
This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.