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.
Cleanser, Root Canal
Unknown
Root Canal Cleanser is a dental device used during endodontic treatment to irrigate, dissolve organic debris, and disinfect the root canal system, removing pulp tissue remnants and microorganisms to prepare the canal for filling and sealing. This device is currently unclassified by the FDA, meaning it has not been placed into a risk class through the standard classification process, and a 510(k) submission has been required pending classification. The product code is KJJ; no regulation number or medical specialty code has been assigned.
510(k) Clearances
41 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.