BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARCHTEK, INC.

    Reg #: 1723435 · FEI: 3000203342 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    ARCHTEK, INC.
    Registration Number
    1723435
    FEI Number
    3000203342
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11405 N. Pennsylvania St., Suite 106
    City
    Carmel
    State
    IN
    ZIP
    46032
    Country
    US

    Regulatory Submissions

    510(k) Number
    K073446

    Owner / Operator

    Firm Name
    ARCHTEK, INC.
    Operator Number
    9025130
    Address
    11405 N Pennsylvania Street, Suite 106
    City
    Carmel
    State
    IN
    Postal Code
    46032
    Country
    US
    Correspondent
    Reed Elder

    Products

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

    Proprietary Names

    Archtek Dental Grind Guard +Sport Archtek Dental Grind Guard

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility