Clearance Summary
AMALGAMATOR MODEL SDC-- received FDA 510(k) clearance under submission number K791410, sponsored by Sierra Laboratories, 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 1979-09-19.
- Submission: K791410
- Applicant / Sponsor: Sierra Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3100
- Decision date: 1979-09-19
Classification & Regulation
This clearance is catalogued under FDA product code EFD and 21 CFR 872.3100, within the Dental review panel as a Class I device.