BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Visible Light Cure Luting

    Reg #: 3013410675 · FEI: 3013410675 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ortho Pro Dent LLC
    Registration Number
    3013410675
    FEI Number
    3013410675
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1903 Northgate Blvd,Northogate Executive Center, suite 114
    City
    Sarasota
    State
    FL
    ZIP
    34234
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112574

    Owner / Operator

    Firm Name
    Ortho Pro Dent LLC
    Operator Number
    10053964
    Address
    1903 Northgate Blvd , Northgate Executive center, suite 114
    City
    Sarasota
    State
    FL
    Postal Code
    34234
    Country
    US
    Correspondent
    EDWARD ELIAS

    Products

    Device Name Product Code
    Cement, Dental EMA

    Proprietary Names

    Visible Light Cure Luting Glass Ionomer Cement; Glass Ionomer Restorative Temporary Cement Zinc Oxide Eugenol Cement Polycarboxylate Cement Non Eugenol Temporary Cement Zinc Phosphate Cement Automix Dual Cure Luting Cement Dual Cure Luting Cement Surgical Cement Zinc Oxide Eugenol Reinforced Material Light Cure Glass Ionomer Restorative

    Establishment Types

    Repack or Relabel Medical Device