KOO · Class I · 21 CFR 872.3490

FDA Product Code KOO: Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt

Leading manufacturers include Smithkline Beecham Corp., Procter & Gamble Co. and Block Drug Company, Inc..

4
Total
4
Cleared
137d
Avg days
1986
Since

FDA 510(k) Cleared Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt Devices (Product Code KOO)

4 devices
1–4 of 4
Cleared Nov 30, 1994
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
K945200
Procter & Gamble Co.
Dental · 36d
Cleared Nov 03, 1994
ORAFIX SPECIAL DENTURE ADHESIVE
K943486
Smithkline Beecham Corp.
Dental · 107d
Cleared Feb 01, 1994
PROFAST - DENTURE ADHESIVE FOR LOWER JAWS
K930335
Fittydent-Altwirth & Schmitt GmbH
Dental · 375d
Cleared Aug 29, 1986
NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM
K862876
Block Drug Company, Inc.
Dental · 30d

About Product Code KOO - Regulatory Context