BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    DITRON DENTAL LTD

    Reg #: 3010948854 · FEI: 3010948854 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    45
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    DITRON DENTAL LTD
    Registration Number
    3010948854
    FEI Number
    3010948854
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 Haofe St., Southern Industrial Zone
    City
    Ashkelon Southern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K233231

    Owner / Operator

    Firm Name
    Ditron Dental Ltd
    Operator Number
    10049877
    Address
    2 Haofe St., Southern Industrial Zone
    City
    Ashkelon
    State
    Southern
    Postal Code
    7878002
    Country
    IL
    Correspondent
    Ariel Zuhovitzky

    US Agent

    Business Name
    First Capital Advisers LLC
    Contact Name
    Levent Sadikoglu
    Address
    420 Lexington Ave Rm 1402
    City
    New York
    State
    NY
    ZIP
    10170
    Country
    US
    Email
    [email protected]
    Phone
    212 3170020

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Dental Implant Surgical Tray OFY
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Reflect Recover Implant (NP & RP), Reflect Rapid Implant (NP & RP) Abutment, Implant, Dental Endosseous Recover Cover Screw (NP & RP), Rapid Cover Screw (NP & RP) Castable base abutment (Co- Cr- Mo alloy, Multi-unit abutments, Titanium base abutments, Titanium blank abutments, Cover screws, Healing abutments, Temporary abutments, Prepable straight abutments, Angled abutment, Abutment multi post screw, Multi-unit abutment screw, Multi-unit prosthetic screw. TLI – Tissue Level Precision Implant TLI Overdenture Liberator Abutment in 2, 3, 4 and 5mm Lengths TLI Healing Caps Abutments in 3.5, 4.5, 5.5mm Height TLI Titanium Coping Abutments in 11mm Bridge, 11 Crown, 4.5mm Bridge, 4.5mm Crown Straight Abutment, Anatomic Angulated Abutment, Angulated Abutments, Ball Retained Abutments, Temporary Abutments MPI, CPI, OPI Bar Retained Abutments, Multi-Unit Bar Retained Abutments, Screw Retained Abutment, Cover Screw, Healing Cap Dental Implant Surgical Tray Surgical Kit full, Mini Surgical Kit, Stainless Steel Surgical Tube, Integral Stopper Kit MPI 6mm, MPI OD3.3mm, ULT, API Milled Abutment, Straight MU Abutment, Liberator Abutment TiN Coated TLI Liberator and TLI Overdenture Abutments CC SRA Healing Abutments CC SRA Titanium Coping Abutments CC Liberator Overdenture Abutments CC Cover Screw CC Temporary Titanium Abutments CC Cement Retained Abutments Laser Marked Titanium Abutments TiN Coated Overdenture Abutments CC Healing Caps MPC, APC, UPC, CPC Implants CC Screw-Retained Abutments (Single-unit Abutments and Multi-Unit Abutments) CC Prosthetic Screw CC Temporary PEEK Abutments Reflect Rapid Ratchet Connector Assembly, Long and Short Short Hand key 1.25 mm, Long Motor insertion tool, Long Motor Adaptor, Short Motor Insertion tool, Short Motor Adaptor, Drill extender Marking drill 1.9mm, Pilot drill 2mm, Twist Drill 2.5mm, Twist Drill 2.8mm, Twist Drill 3.2 mm, Short Twist Drill 2.5 / 2.8 / 3.2 / 3.8 / 4.5 / 5 / 5.5 mm, Guided Step Drill, Milling Drill, Tissue Punch, Twist Drill 3.8 mm, Twist Drill 4.5 mm, Twist Drill 5 mm, Twist Drill 5.5 mm, Short Pilot drill 2 mm, Countersink - Standard platform OD 3.75 / 4.2mm, Countersink - wide platform OD 5 / 6mm, Trephine Drill, Stopper Twist Drill. Casting Abutment, Guided Anchoring Screw, Guided Fixation Pin, Guided Insertion Mount, Guided Sleeve, Impression Coping Transfer, Impression Coping Analog, Insertion Drivers, Multi-Unit Driver, Depth Probe, Long hand and ratchet insertion tool, Short hand & ratchet insertion tool, Long Hand key 1.25 mm, Overdenture Processing Components, Prosthetic Screwdrivers, Tool Extractor. Parallel pin, Long ratchet key 1.25mm, Short ratchet key 1.25mm, Ratchet wrench, Ratchet torque Straight multiunit key Accelx dental implants Accelx cover screws

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device