BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KeySplint Soft

    Reg #: 2523320 · FEI: 2523320 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Keystone Industries
    Registration Number
    2523320
    FEI Number
    2523320
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    52 West King St
    City
    Myerstown
    State
    PA
    ZIP
    17067
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183598

    Owner / Operator

    Firm Name
    Keystone Industries
    Operator Number
    9007845
    Address
    480 S. Democrat Road, --
    City
    Gibbstown
    State
    NJ
    Postal Code
    08027
    Country
    US

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC
    Positioner, Tooth, Preformed KMY

    Proprietary Names

    KeySplint Soft

    Establishment Types

    Manufacture Medical Device