BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ESSENTIAL DENTAL SYSTEMS, INC.

    Reg #: 2433629 · FEI: 2433629 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    ESSENTIAL DENTAL SYSTEMS, INC.
    Registration Number
    2433629
    FEI Number
    2433629
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    89 LEUNING ST.
    City
    S Hackensack
    State
    NJ
    ZIP
    07606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K134022

    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
    Liner, Cavity, Calcium Hydroxide EJK
    Gauge, Depth, Instrument, Dental EIL
    Tray, Fluoride, Disposable KMT
    Drill, Dental, Intraoral DZA
    Tray, Surgical, Instrument FSM
    Agent, Tooth Bonding, Resin KLE
    Cement, Dental EMA
    Light, Surgical Headlight EBA
    Post, Root Canal ELR
    Cleanser, Root Canal KJJ
    Material, Tooth Shade, Resin EBF
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Mirror, Mouth EAX
    Gutta-Percha EKM
    Scaler, Ultrasonic ELC
    Resin, Root Canal Filling KIF
    Handpiece, Direct Drive, Ac-Powered EKX
    Instrument, Filling, Plastic, Dental EIY
    Handle, Instrument, Dental EJB
    Reamer, Pulp Canal, Endodontic EKP

    Proprietary Names

    Bio-LCB EDS Depth Gauge Countersink Drill Primary Reamer, Secondary Drill, Gates Glidden Drill, Peeso Reamer, Pleezer Reamer Steri Tracker EDS Self Etch Bonding Agent Flexi-Flow Auto E Endo CSV LED Light Flexi-Post, Flexi-Overdenture, Flexi-Flange, EDS' AccessPost, EDS AccessPost Overdenture, EZ Fit Translucent ENDO-CHX Ti-Core Flow Plus, Ti-Core Auto E EDTA Plus Ti-Core Endo-Express C-MOR CEMPOWER SafeSiders Gutta Percha Points Safesider HF Gutta Percha Points Turbo-CR EZ-Fill Bi-Directional Spiral EZ-Fill Cement EZ-Fill Root Canal Cement Endo CSV Hand Piece EDS Mixing Tips, OVD Caps Irritrol BioSeal Wrench Ti-Core Natural SafeSiders Safesider HF EZ-Fill Xpress

    Establishment Types

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