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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: MQC FDA unclassified

    Mouthguard, Prescription

    Unknown

    View full classification →

    The Prescription Mouthguard is a dental device custom-fabricated under a dentist's prescription for use in protecting teeth and oral structures, commonly used to manage bruxism (teeth grinding), temporomandibular disorders, or during contact sports. This device is currently unclassified by the FDA, meaning its formal regulatory classification is pending. The product code is MQC, reviewed by the Dental panel.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Hard Splint & Thermo-Adaptive Splint
    Remi Custom Night Guard
    LIJIA Night Guard
    GR Resin System MSI
    Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
    Slow Wave DS8 (SWDS802)
    RODIN 3D Resin SPLINT, Hard/Flex
    Dental LT Comfort Resin
    Myoaligner Appliance
    LuxCreo Dental Night Guard Resin
    Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
    Serena Sleep Night Guard
    FREEPRINT® splintmaster
    Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
    dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
    Glidewell TuffSplint™ Appliance Resin
    Dental LT Clear V2 Resin
    NextDent Ortho Flex
    SmileGuard
    Thermeo System
    Glidewell Appliance Resin, Hard/Soft
    SleepRight Select-Comfort Dental Guard
    NightGuard Flex
    GR Splint Resin System
    LuxaPrint Ortho Plus
    JS Dental Lab Mouth Guard
    Panthera Occlusal Appliance
    KeyPrint KeySplint Hard
    E-Guard
    Night Guard
    V-Print splint
    Thermoforming Sheet Materials
    Ceramill A-Splint
    KeyPrint KeySplint Soft
    The POD
    VeriSplint
    Brux Night Guard
    Urbanek Device
    Ortho System
    BRX PRO Bruxism Guard
    SICAT OPTIMOTION
    Narval Brux
    M-PM-DISC
    SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
    THERMOFORMED MOUTHGUARDS
    DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
    SOMNOBRUX SPLINTS
    MIGRA TAB, QUICKSPLINT MIGRAINE
    CLEARSPLINT ES
    FREEWAY COMFORT BITE GUARD

    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.

    Popular Product Codes

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