510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Dental
This device is a denture adhesive formulated with polyvinyl methylether maleic acid calcium-sodium double salt, used to help retain removable dentures in place within the oral cavity. It is classified as FDA Class 1, meaning it presents low risk and is subject only to general controls such as proper labeling and manufacturing standards. The product code is KOO, and it is regulated under 21 CFR 872.3490 within the Dental specialty. No special flags apply to this device.
510(k) Clearances
4 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.