Clearance Summary
OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT received FDA 510(k) clearance under submission number K801779, sponsored by Oxy Dental Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-08-07.
- Submission: K801779
- Applicant / Sponsor: Oxy Dental Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3275
- Decision date: 1980-08-07
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.