BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Adhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock

    Reg #: 1718476 · FEI: 1718476 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    RMO
    Registration Number
    1718476
    FEI Number
    1718476
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2165 Earlywood Drive
    City
    Franklin
    State
    IN
    ZIP
    46131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072830

    Owner / Operator

    Firm Name
    RMO
    Operator Number
    10078580
    Address
    2165 Earlywood Drive
    City
    Franklin
    State
    IN
    Postal Code
    46131
    Country
    US
    Correspondent
    Brandon Bernacchi

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF
    Adhesive, Bracket And Tooth Conditioner, Resin DYH

    Proprietary Names

    Adhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock

    Establishment Types

    Repack or Relabel Medical Device