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.
Facebow
Dental
A facebow is a dental measurement device used to register and transfer the spatial relationship of the maxillary teeth to the temporomandibular joint and the axis of mandibular rotation, enabling accurate mounting of dental casts on an articulator for the fabrication of prostheses or occlusal adjustments. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls. Product code KCR is regulated under 21 CFR 872.3220 in the Dental medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.
510(k) Clearances
1 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.