BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    TMA Cementing Cone

    Reg #: 3007518363 · FEI: 3007518363 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ADIN DENTAL IMPLANT SYSTEMS LTD.
    Registration Number
    3007518363
    FEI Number
    3007518363
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Alon Tavor Industrial Zone, POB 1128
    City
    Afula Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K140293

    Owner / Operator

    Firm Name
    ADIN DENTAL IMPLANT SYSTEMS Ltd
    Operator Number
    10028570
    Address
    Industrial Zone
    City
    Alon Tavor
    State
    Northern
    Postal Code
    1811101
    Country
    IL
    Correspondent
    Ilana Lutvak

    US Agent

    Business Name
    ADIN DENTAL SOLUTIONS USA, INC.
    Contact Name
    Ksenija Batistich
    Address
    560 Sylvan Avenue, Suite 3160
    City
    Englewd Clfs
    State
    NJ
    ZIP
    07632
    Country
    US
    Email
    [email protected]
    Phone
    201 3742592

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    TMA Cementing Cone Ti Bases for Touareg CloseFit NP dental implants (Engaged, Non-Engaged, Angular Engaged), NP C-Type Ti Base Gold / Plastic abutments for NP (engaging and non-engaging) Cement retained abutments for NP (straight, angled 15deg, angled 25deg, temporary) Overdenture abutments for NP (Ball attachments 0.5-5mm, cylindrical grip 2-6mm) Screw retained abutments for NP (Straight TMA 1-5mm, angled 17deg and 30deg) Healing abutments for NP (regular 4.5mmD, slim 3mmD, conical 4.5mmD) Screw retained abutments for NP (Flat connection abutment 2, 4mm) IRIS™, NP Platform TMA components (TMA healing cap, TMA titanium temporary copying) Retaining screws for NP TMA abutments (straight and angled) NP CloseFit™ Ti Pre Milled MDTK Abutment Blank IRIS™, NP Snap-on Impression Kit NP and TMA Grip Abutments Screw retained abutments for NP (straight single TMA 1-5mm, Angled single TMA 17° 3-4mm, Angled single TMA 30° 3.5-5mm)

    Establishment Types

    Manufacture Medical Device