Clearance Summary
PLY LESIVE received FDA 510(k) clearance under submission number K801047, sponsored by May-Pell Chemical Development 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 1980-05-20.
- Submission: K801047
- Applicant / Sponsor: May-Pell Chemical Development Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 1980-05-20
Classification & Regulation
This clearance is catalogued under FDA product code LBH and 21 CFR 872.3260, within the Dental review panel as a Class II device.