BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ADIN UNIFIT DENTAL IMPLANT SYSTEM

    Reg #: 3007518363 · FEI: 3007518363 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    2
    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
    K223714

    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
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    ADIN UNIFIT DENTAL IMPLANT SYSTEM UniFit Ti Pre Milled MDTK Abutment Blank Screw retained abutments for UniFit dental implants (straight TMA 1-5mm, angled TMA 17-30 deg 2.5-4mm) UniFit Overdenture abutments (Ball Attachments 0.5-5mm, Grip abutments 1-6mm) UniFit Flat Connection Abutments (2mm, 4mm) Single TMA Cementing Cone TMA Cementing Cone UniFit Ti Bases (Engaged, Non-Engaged, Angular Engaged), UniFit C-Type Ti Base UniFit Cement retained abutments (straight, angled 15, angled 25) UniFit Retaining screws for TMA abutments (straight and angled) UniFit Straight Single TMA (Straight 1-5mm, Angled 17°-30°) Touareg UniFit Dental Implants ( 3.5-6mmD 6-18mmL) UniFit Healing Abutment 3.5-5.5mmD 2-6mmL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device