BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NiteBite¿

    Reg #: 3009133124 · FEI: 3009133124 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    RANDMARK DENTAL PRODUCTS, LLC
    Registration Number
    3009133124
    FEI Number
    3009133124
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    284 Elkins Ln
    City
    Lusby
    State
    MD
    ZIP
    20657
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110468

    Owner / Operator

    Firm Name
    Randmark Dental Products, LLC
    Operator Number
    10037706
    Address
    284 Elkins Ln
    City
    Lusby
    State
    MD
    Postal Code
    20657
    Country
    US
    Correspondent
    Randy Widen

    Products

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

    Proprietary Names

    NiteBite¿

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility