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.
Heat Source For Bleaching Teeth
Dental
The Heat Source for Bleaching Teeth is a dental device used to generate and apply heat to activate bleaching agents during in-office tooth whitening procedures, accelerating the chemical reaction that lightens tooth stains and discoloration. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EEG and the applicable regulation is 21 CFR 872.6475, under the Dental medical specialty.
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.