BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD)

    Reg #: 3015547648 · FEI: 3015547648 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    LATE NIGHT CONCEPTS INC. (DBA BRUX NIGHT GUARD)
    Registration Number
    3015547648
    FEI Number
    3015547648
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8201 Canoga Ave. Unit 9066
    City
    Canoga Park
    State
    CA
    ZIP
    91309
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181361

    Owner / Operator

    Firm Name
    Late Night Concepts Inc. (DBA Brux Night Guard)
    Operator Number
    10060442
    Address
    8201 Canoga Ave. Unit 9066
    City
    Canoga Park
    State
    CA
    Postal Code
    91309
    Country
    US
    Correspondent
    John Scalco

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC
    Cleaner, Ultrasonic, Medical Instrument FLG
    Pack, Hot Or Cold, Reusable IME

    Proprietary Names

    Brux Night Guard Ultrasonic UV Cleaner DoloPad

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198