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    K Number
    K162482
    Device Name
    A.B. DENTAL DEVICES Dental Implants System
    Manufacturer
    A. B. Dental Device Ltd.
    Date Cleared
    2017-09-15

    (374 days)

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

    A. B. Dental Device Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A.B. DENTAL DEVICES® 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. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: I22, I5, I55, I10. P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.
    Device Description
    A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added: | Implant | Platform | Diameter, mm | Length, mm | |---------|----------|--------------|---------------------| | I22 | Standard | 3.75 | 8, 10, 11.5, 13, 16 | | | | 4.2 | 8, 10, 11.5, 13, 16 | | | | 4.5 | 8, 10, 11.5, 13, 16 | | | | 5 | 8, 10, 11.5, 13, 16 | | I5 | Narrow | 3.3 | 10, 11.5, 13, 16 | | I55 | Narrow | 3.3 | 10, 11.5, 13, 16 | | | | 3.5 | 8, 10, 11.5, 13, 16 | | | Standard | 3.75 | 8, 10, 11.5, 13, 16 | | | | 4.2 | 8, 10, 11.5, 13, 16 | | | | 4.5 | 8, 10, 11.5, 13, 16 | | | | 5 | 8, 10, 11.5, 13, 16 | | | | 6 | 8, 10, 11.5, 13, 16 | | I10 | Standard | 4.5 | 10, 11.5, 13, 16 | Abutments: - P0-14 Healing caps, 2.5 7 mm heights . - P3-5 straight abutments, 5 mm diameter, 7 9 mm length ● - P4 angled abutments, 15 - 25 degree angulation, standard platform, standard and long lengths
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