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.
Bone Grafting Material, Human Source
Dental
The Human Source Dental Bone Grafting Material is an implantable device derived from human bone intended to fill bony voids or gaps in dental, oral, and craniofacial/maxillofacial defects, including periodontal and infrabony defects, alveolar ridge augmentation, dental extraction sites, sinus lifts, cystic defects, and craniofacial augmentation procedures. It is an FDA Class 2 implant regulated under 21 CFR 872.3930 in the Dental specialty, with product code NUN, requiring 510(k) clearance. The implant flag is set reflecting its surgical placement in osseous defects. It does not carry life-sustaining support designation.
510(k) Clearances
15 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.