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.
Dental Abutment Design Software For Dental Laboratory
Dental
The Dental Abutment Design Software For Dental Laboratory (product code PNP) is a Class 2 dental device intended to aid in the restoration of chewing function by enabling a dental laboratory or dental clinician to design and fabricate the patient-specific component of a dental abutment, regulated under 872.3630. It requires 510(k) clearance and is flagged as an implant because the resulting abutment component is implanted as part of a dental implant system. The abutment-to-implant interface connection platform is not a patient-specific component.
510(k) Clearances
8 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.