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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: LRK FDA class 2

    Device, Anti-Snoring

    Dental

    View full classification →

    The Anti-Snoring Device is a dental appliance designed to reposition the mandible or maintain airway patency during sleep to reduce or eliminate snoring, typically through oral repositioning mechanisms. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LRK, regulated under 21 CFR 872.5570, within the Dental medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Virtus
    Snorbliss® Anti-Snoring Device
    Dormiva Anti-Snoring Mouth Guard
    ShaeferH
    Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
    Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
    Park Dental Nylon MAD
    QuietLab Pro
    Hushd Avera
    AIO Breathe
    NightGuard Aire Max
    Difiney Advanced Anti Snoring Device 4.0
    Hushd Pro Z-Link
    Mandibular Advancement Device L07
    Anti Snore Mouthpiece
    Double Tube Herbst Appliance
    Nylon flexTAP(R)
    Oniris; Oniris Plus
    SleepRight Snore Aid
    Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
    DNA Appliance
    Hushd Pro Avera
    EMA 3D
    Difiney Anti Snoring Device
    airVata™
    Aniti-Snore Mouthguard+
    C.A.R.E. Appliance (DNA, mRNA, mmRNA)
    Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
    The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
    ApneaRX Pro
    Emerald Herbst
    DNA Appliance
    SilentZPro 2.0
    SNOR LOCK
    CUSTMBITE Snoring System
    Soft Palate Elevator
    ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
    Soundly Anti Snoring Device
    ZQuiet Advance
    Respire Clear
    Morpheus
    Elevo Snoring Intervention Set
    EndSnorZ Sleep Appliance
    SmartGuard Anti-Snoring Device
    mmRNA appliance
    Snore Bandit
    Silent Nite Sleep Appliance with the Glidewell Hinge
    Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
    Classic
    Advanced Dental Appliance

    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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