BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Koncept Innovators, LLC

    Reg #: 3010358861 · FEI: 3010358861 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Koncept Innovators, LLC
    Registration Number
    3010358861
    FEI Number
    3010358861
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1619 Executive Ave
    City
    Myrtle Beach
    State
    SC
    ZIP
    29577
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201484

    Owner / Operator

    Firm Name
    Koncept Innovators, LLC
    Operator Number
    10059662
    Address
    1619 Executive Ave
    City
    Myrtle Beach
    State
    SC
    Postal Code
    29577
    Country
    US
    Correspondent
    Sylvan Newby

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK
    Device, Jaw Repositioning LQZ
    Mouthguard, Over-The-Counter OBR

    Proprietary Names

    Tranquility PRO 2 Anti-Snoring Mouth Guard Tranquility PRO Bright Guard Pro 2 Tranquility Eliminator Pro 2 Tranquility Pro 2 Somnos Pro 2 Tranquility Anti-Snoring Mouth Guard Tranquility PRO Anti-Snoring Mouth Guard Intelliguard Pro Serenity Pro 2 Somnos Anti-Snoring Mouth Guard Eliminator Pro Bright Guard 2 Bright Guard Intelliguard Eliminator Serenity Dormiva Anti-Snoring Mouth Guard

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility