Clearance Summary
NICO DENTAL ALLOY received FDA 510(k) clearance under submission number K924716, sponsored by Co-Nick Alloys (India) , 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 1994-01-21.
- Submission: K924716
- Applicant / Sponsor: Co-Nick Alloys (India) , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 1994-01-21
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.