Clearance Summary
VISION PROPHY PASTE WITHOUT FLUORIDE received FDA 510(k) clearance under submission number K933893, sponsored by Block Drug Company, 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 1993-11-16.
- Submission: K933893
- Applicant / Sponsor: Block Drug Company, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6030
- Decision date: 1993-11-16
Classification & Regulation
This clearance is catalogued under FDA product code EJR and 21 CFR 872.6030, within the Dental review panel as a Class I device.