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.
Oral Wound Dressing
Unknown
The Oral Wound Dressing (product code OLR) is an unclassified device reviewed by the Dental (DE) panel that cleared 510(k) review but remains without formal classification, with unclassified status established via a substantial equivalence determination. It is intended to function as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. The device is not an implant and is not life-sustaining.
510(k) Clearances
35 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.