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510(k) Data Aggregation

    K Number
    K120530
    Device Name
    DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S
    Manufacturer
    DENTIN IMPLANTS TECHNOLOGIES LTD.
    Date Cleared
    2012-07-05

    (134 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTIN IMPLANTS TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DENTIN® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. DENTIN® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: CLASSIC, RAPID, PRESTIGE. One Stage Implants: ONE PIECE DENTIN® ONEPIECE Implants 3.0 mmd are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.
    Device Description
    DENTIN® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants system; cover screws and healing caps; abutment systems and superstructures; impression copy system & surgical instruments.
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