Clearance Summary
HOWMEDICA WHITE C&B ALLOY received FDA 510(k) clearance under submission number K801009, sponsored by Dental Laboratory Products Div.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-06-04.
- Submission: K801009
- Applicant / Sponsor: Dental Laboratory Products Div.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 1980-06-04
Classification & Regulation
This clearance is catalogued under FDA product code EJS and 21 CFR 872.3060, within the Dental review panel as a Class II device.