Clearance Summary
AMALGAM DISPENSER received FDA 510(k) clearance under submission number K771749, sponsored by New Dimensions IN Medicine, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-09-28.
- Submission: K771749
- Applicant / Sponsor: New Dimensions IN Medicine, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3080
- Decision date: 1977-09-28
Classification & Regulation
This clearance is catalogued under FDA product code EHE and 21 CFR 872.3080, within the Dental review panel as a Class I device.