BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SmartGuard Elite

    Reg #: 3013652641 · FEI: 3013652641 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SMARTGUARD RX INC
    Registration Number
    3013652641
    FEI Number
    3013652641
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    201 East 2150 North, Unit E
    City
    Layton
    State
    UT
    ZIP
    84041
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123161

    Owner / Operator

    Firm Name
    SmartGuard Rx Inc
    Operator Number
    10055164
    Address
    201 East 2150 North, Unit E
    City
    Layton
    State
    UT
    Postal Code
    84041
    Country
    US
    Correspondent
    Brian Larsen

    Products

    Device Name Product Code
    Mouthguard, Over-The-Counter OBR
    Mouthguard, Prescription MQC

    Proprietary Names

    SmartGuard Elite SmartGuard Night Guard SmartGuard Dental Guard SmartGuard Elite Night Guard

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility