Clearance Summary
ACCU-MIX AMALGAMATOR received FDA 510(k) clearance under submission number K910632, sponsored by Wykle Research, 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 1991-03-15.
- Submission: K910632
- Applicant / Sponsor: Wykle Research, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3100
- Decision date: 1991-03-15
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.