Clearance Summary
ZINC OXIDE EUGENOL TEMPORARY CEMENT received FDA 510(k) clearance under submission number K883698, 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 1988-11-29.
- Submission: K883698
- Applicant / Sponsor: E&D Dental Manufacturing Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 1988-11-29
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.