Clearance Summary
EUGENOL USP received FDA 510(k) clearance under submission number K862745, sponsored by E&D Dental Manufacturing 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 1986-07-31.
- Submission: K862745
- Applicant / Sponsor: E&D Dental Manufacturing Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3275
- Decision date: 1986-07-31
Classification & Regulation
This clearance is catalogued under FDA product code EMB and 21 CFR 872.3275, within the Dental review panel as a Class I device.