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    Tool · 510(k)

    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.

    Product Code: JEY FDA class 2

    Plate, Bone

    Dental

    View full classification →

    A Dental Bone Plate is a surgical implant used in oral and maxillofacial surgery to stabilize and fix fractured or osteotomized bone segments of the jaw, providing rigid internal fixation to support healing. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JEY, regulated under 21 CFR 872.4760, within the Dental medical specialty. This device is flagged as an implant reflecting its placement within osseous tissue.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    KLS Martin Oral-Max Implants MR Conditional (bundled)
    MRI Universal
    tmCMF Solution
    METICULY Patient-specific titanium maxillofacial mesh implant
    Stryker Facial iD System
    MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
    Stryker Resorbable Fixation System
    Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate
    Tandry CMF Plate System
    Universal CMF System
    KLS Martin Individual Patient Solutions
    Stryker Resorbable Fixation System
    Biomet Microfixation OmniMax MMF System
    OsteoSync™ Ti Dental Mesh
    TECHFIT Patient-Specific Maxillofacial System
    MedCAD® AccuPlate® Patient-Specific Plate
    DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
    BoniPlus Dental G-Mesh System
    Yxoss CBR®
    FAICO CMF System
    Stryker Facial iD Plating System
    Stryker Customized Mandible Recon Plate Kit
    Depuy Synthes Maxillofacial Portfolio - MR Conditional
    MCI - CMF System
    KLS Martin Individual Patient Solutions
    Stryker Surgeon iD Mandible Recon Plate
    Delphos Implants Rigid Fixation System
    Stryker Facial iD Plating System
    CranioMaxillofacial Fixation (CMF) System - CMF Visionare
    OmniPore DUROMAX Surgical Implants
    KLS Martin Individual Patient Solutions
    TruMatch CMF Titanium 3D Printed Implant
    GBR system
    OssBuilder System
    KLS Martin L1 MMF System
    KLS Martin Individual Patient Solutions
    Stryker Universal Mesh
    Stryker Upper-Face AXS screws and Mid-Face AXS screws
    TruMatch CMF Titanium 3D Printed Implant System
    MP LeFort I Plates
    OPTIMUS CMF SYSTEM
    Biomet Microfixation OmniMax MMF System
    LeForte System II
    GBR System
    Stryker MEDPOR TITAN 3D Orbital Floor Implant
    Biomet Microfixation OmniMax MMF System
    Argulated Locking Plates
    OPTIMUS CMF SYSTEM
    OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM
    TRISTAR BONE GRAFT FIXATION SYSTEM

    What 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.

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