Clearance Summary
BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI received FDA 510(k) clearance under submission number K926121, sponsored by Dentmed , 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 1994-02-03.
- Submission: K926121
- Applicant / Sponsor: Dentmed , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6770
- Decision date: 1994-02-03
Classification & Regulation
This clearance is catalogued under FDA product code EJI and 21 CFR 872.6770, within the Dental review panel as a Class II device.