DeviceClearance

Product code KOO— Dental

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

Classification name
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Device class
Class 1
Regulation
21 CFR 872.3490
Advisory panel
Dental
Total cleared
4
First cleared
Most recent

Market context for product code KOO

FDA has cleared 4 devices under product code KOO between 1986 and 1994, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code KOO

Recent clearances under product code KOO

Data sourced from openFDA. This site is unofficial and independent of the FDA.