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.
Tray, Impression, Preformed
Dental
The Preformed Impression Tray is a prefabricated, standardized tray made of metal or plastic used to hold impression material in the correct position while it sets, allowing dental practitioners to capture an accurate three-dimensional record of oral structures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHY, regulated under 21 CFR 872.6880 in the Dental (DE) specialty. This device is exempt from GMP requirements.
510(k) Clearances
16 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.