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.
Diagnostic Light, Soft Tissue Detector
Dental
The Diagnostic Light, Soft Tissue Detector (product code NXV) is a dental diagnostic device that uses light to aid in the detection or visualization of abnormalities of intraoral soft tissue, serving as an adjunct to traditional intraoral examination by incandescent light to enhance visualization of oral mucosal abnormalities. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 872.6350 within the Dental specialty. Third-party 510(k) review is available for this device type.
510(k) Clearances
12 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.