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.
Locator, Root Apex
Unknown
A root apex locator is a dental electronic device used during endodontic procedures to determine the position of the root apex and the length of the root canal, enabling more precise and safe cleaning and filling of the canal. This device is currently unclassified (Class U) by the FDA, meaning it has not yet been placed into a final regulatory classification category. The product code is LQY; no regulation number or medical specialty is on file for this entry. No special flags apply to this device.
510(k) Clearances
45 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.