Clearance Summary
SUPER POLI-GRIP DENTURE ADHESIVE CREAM received FDA 510(k) clearance under submission number K945462, 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 1994-12-20.
- Submission: K945462
- Applicant / Sponsor: Block Drug Company, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3490
- Decision date: 1994-12-20
Classification & Regulation
This clearance is catalogued under FDA product code KOT and 21 CFR 872.3490, within the Dental review panel as a Class I device.