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.
Cord, Retraction
Unknown
A Retraction Cord is a dental device, typically made of braided cotton fibers, inserted into the gingival sulcus around a prepared tooth to temporarily displace and retract gingival tissue and control fluid, providing a clear field for impression taking or other restorative procedures. This device has an unclassified status (class "U") in the FDA database. The product code is MVL with no regulation number assigned, and the device is not an implant and is not life-sustaining.
510(k) Clearances
33 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.