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.
Mouthguard, Over-The-Counter
Unknown
The Over-The-Counter Mouthguard (product code OBR) is a dental device intended to protect the teeth and reduce damage caused by bruxism or nighttime teeth grinding, as well as to prevent the noise associated with grinding. It is sold directly to consumers without a prescription for self-management of bruxing habits. This device is FDA Unclassified (class U), meaning it has not been formally placed into a device class and the unclassified reason code indicates it is pending classification; it has no regulation number and no assigned medical specialty. It carries no implant or life-sustaining flags.
510(k) Clearances
41 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.