Clearance Summary
STEADFAST DENTURE ADHESIVE POWDER received FDA 510(k) clearance under submission number K910216, sponsored by Stiefel Research Institute, 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 1991-03-29.
- Submission: K910216
- Applicant / Sponsor: Stiefel Research Institute, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3400
- Decision date: 1991-03-29
Classification & Regulation
This clearance is catalogued under FDA product code KOM and 21 CFR 872.3400, within the Dental review panel as a Class I device.