Clearance Summary
HOWMEDICA BRASS CENTER DISC received FDA 510(k) clearance under submission number K790640, sponsored by E.C. Moore Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1979-05-01.
- Submission: K790640
- Applicant / Sponsor: E.C. Moore Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6010
- Decision date: 1979-05-01
Classification & Regulation
This clearance is catalogued under FDA product code EHJ and 21 CFR 872.6010, within the Dental review panel as a Class I device.