Clearance Summary
ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT received FDA 510(k) clearance under submission number K955089, sponsored by Wallace A. Erickson & 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 1995-12-13.
- Submission: K955089
- Applicant / Sponsor: Wallace A. Erickson & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 1995-12-13
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.