Clearance Summary
CAVI-ZYME received FDA 510(k) clearance under submission number K922633, sponsored by E&D 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 1992-08-06.
- Submission: K922633
- Applicant / Sponsor: E&D Dental Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1992-08-06
Classification & Regulation
This clearance is catalogued under FDA product code EJB and 21 CFR 872.4565, within the Dental review panel as a Class I device.