Cleared Traditional

FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES

K945200 · Procter & Gamble Co. · Dental

Nov 1994

Decision

36d

Days

Class 1

Risk

About This 510(k) Submission

K945200 is an FDA 510(k) clearance for the FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES, a Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt (Class I — General Controls, product code KOO), submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on November 30, 1994, 36 days after receiving the submission on October 25, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3490.

Submission Details

510(k) Number	K945200 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 1994
Decision Date	November 30, 1994
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	KOO — Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt
Device Class	Class I — General Controls
CFR Regulation	21 CFR 872.3490