BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Endo-Express

    Reg #: 2433629 · FEI: 2433629 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ESSENTIAL DENTAL SYSTEMS, INC.
    Registration Number
    2433629
    FEI Number
    2433629
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    89 LEUNING ST.
    City
    S Hackensack
    State
    NJ
    ZIP
    07606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K962540

    Owner / Operator

    Firm Name
    ESSENTIAL DENTAL SYSTEMS, INC.
    Operator Number
    2433629
    Address
    89 LEUNING ST., --
    City
    South Hackensack
    State
    NJ
    Postal Code
    07606
    Country
    US
    Correspondent
    JOEL - BURSTEIN

    Products

    Device Name Product Code
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS

    Proprietary Names

    Endo-Express

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility