BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    IRIS", WP Snap-on Impression Kit

    Reg #: 3007518363 · FEI: 3007518363 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    22
    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
    K112585

    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

    IRIS", WP Snap-on Impression Kit Flat Connection system for RS implants (abutments, temporary sleeve, gluing ring, retaining screw) Cement retained abutments for RP and WP (straight, straight slim, angled 15deg, temporary) Titanium / Plastic abutments for RP and WP (engaging and non-engaging) Screw retained abutments for RP and WP (Straight TMA 1-5mm, angled 17deg and 30deg) IRIS", RP Platform IRIS", WP Platform RP WP CloseFit" Ti Pre Milled MDTK Abutment Blank Overdenture abutments for RP and WP (Ball attachments 0.5-5mm, cylindrical grip 2-6mm) Touareg CloseFit RP and WP Ti Bases (Engaged, Non-Engaged, Angular Engaged), RP and WP C-Type Ti base Screw retained abutments for RP and WP (Flat connection abutment 2, 4mm) Swell, Touareg-S, Touareg-OS dental implants in 18mmL Cement retained abutments for RS implants (straight cylindrical, one piece screw-in, wide profile, slim 3mm, angled long IRIS", RP Snap-on Impression Kit Retaining screws for RP and WP TMA abutments (straight and angled) Healing Abutments for RP and WP implants (regular, slim, conical) Overdenture abutments for RS implants (cylindrical grip 2-6mm) WP and RP Touareg CloseFit Dental Implants Healing abutments for RS implants (Wide 6mmD, Slim 3.5mmD) Titanium / Plastic abutments for RS implants (engaging and non-engaging) Screw retained abutments for RP(straight single TMA 1-5mm, Angled single TMA 17° 2.5-3.5mm, Angled single TMA 30° 3-4mm) Screw retained abutments for WP(straight single TMA 1-5mm, Angled single TMA 17° 2.5-3.5mm, Angled single TMA 30° 3-4mm)

    Establishment Types

    Manufacture Medical Device