BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Elastomeric Mandibular Advancement (EMA)

    Reg #: 3004038575 · FEI: 3004038575 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    R-DENT DENTAL LABORATORY, INC
    Registration Number
    3004038575
    FEI Number
    3004038575
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7490 Bartlett Corporate Cove West
    City
    Bartlett
    State
    TN
    ZIP
    38133
    Country
    US

    Regulatory Submissions

    510(k) Number
    K971794

    Owner / Operator

    Firm Name
    R-dent Dental Laboratory, Inc
    Operator Number
    10028660
    Address
    7490 Bartlett Corporate Cove West
    City
    Bartlett
    State
    TN
    Postal Code
    38133
    Country
    US
    Correspondent
    Daxton Grubb

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK

    Proprietary Names

    Elastomeric Mandibular Advancement (EMA)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)