BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hema Desensitizer

    Reg #: 3013410675 · FEI: 3013410675 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    32
    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
    K001108

    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
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    Hema Desensitizer Devon - Paste Porcelain Repair Kit Porcelain Etchant Gel Nano composite Light Cure One Step Dentin/Enamel Bonding Adhesive Modifier Separator Visible Light Cure Nano-Hybrid Composite Etchant Liquid Chemical Cure Dentin/Enamel Bonding Adhesive Chemical Cure Composite Restorative Material Devon-Gel Citric Acid Silane Bond Enhancer Devon-Dent Stains Self Etch Bonding Agent Surface Sealant Visible Light Cure Micro-Hybrid Composite Visible Light Cure Composite Restorative Material Light Cure Dentin/Enamel Bonding Adhesive Visible Light Cure Flowable Composite Modeler Visible Light Cure Hybrid Composite Etchant Gel Primer Silane Bond Enhancer; Surface Sealant; Visible Light Cure Composite Restorative Material Devon Dent Dual Cure Core Build Up ,Selfetch one-step bonding Visible Light Cure Flowable Composite; Visible Light Cure Hybrid Composite Hema Desensitizer, Devon Dent Nano-Hybrid Composite refill Visible Light Cure Micro-Hybrid Composite; Visible Light Cure Nano-Hybrid Composite Chemical Cure Composite Restorative Material; Chemical Cure Dentin/Enamel Bonding Adhesive Porcelain Etchant Gel; Devon - Paste Porcelain Repair Kit; Self Etch Bonding Agent;

    Establishment Types

    Repack or Relabel Medical Device