Clearance Summary
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES received FDA 510(k) clearance under submission number K945200, sponsored by Procter & Gamble Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-11-30.
- Submission: K945200
- Applicant / Sponsor: Procter & Gamble Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3490
- Decision date: 1994-11-30
Classification & Regulation
This clearance is catalogued under FDA product code KOO and 21 CFR 872.3490, within the Dental review panel as a Class I device.