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510(k) Data Aggregation

    K Number
    K132125
    Device Name
    A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM
    Manufacturer
    A.B. DENTAL DEVICES, LTD.
    Date Cleared
    2014-01-21

    (195 days)

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

    A.B. DENTAL DEVICES, 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: 12, 15, 16BI. One Stage: 16, 16b, 16B. One Stage & One-Piece 3.0 mm diameter implants: 16, 16B1, are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants. One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: 16, 16b, permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis. P14 Angulated Abutment Adapter is to be used with implant diameter 4.2mm and higher.
    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 system; l2 - Screw Type Implant - Diameter 3.5, Length 8, 10,11.5,13,16 l5 - Conical Implant - Diameter 3.5, Length 8, 10,11.5,13,16 16 - Narrow Integral Implant - Diameter 2.4, 3, 3.2 Length 10, 11.5, 13, 16 l6b - Ball Attachment Implant - Diameter 2.4 Length 10, 11.5, 13, 16 16B - Narrow Implant - Diameter 3, 3.2 Length 10, 11.5, 13, 16 16BI - Narrow Implant - Diameter 3 Length 10, 11.5, 13, 16 Abutments System consists of healing caps, screws, Anti-rotation Abutment, Anatomic Anti-rotation Abutment, Narrow / Wide Anti-rotation Abutment, Zirconium Anatomic Abutment, Temporary PEEK Anatomic Anti-rotation Abutment, Long Angular Abutment 15°, Anatomic Angular Abutment 15°, Ball Attachment Abutment, Angular Ball Attachment 20°, Ball for Angular Adaptor, Titanium Sleeve, Anti-rotation Aesthetic Abutment, Composed Hex/Non Hex Abutment, Angular Adaptor, Locator and other superstructures; impression copy system & surgical instruments are also provided.
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    K Number
    K112440
    Device Name
    AB DENTAL DEVICES IMPLANTS AND ACCESSORIES
    Manufacturer
    A.B. DENTAL DEVICES, LTD.
    Date Cleared
    2012-04-18

    (238 days)

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

    A.B. DENTAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AB Dental Devices implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. 17 Integral implant, 15 Conical implant, P15 Temporary abutment, P12-T,L Temporary flat connection abutment, and P16 Straight adaptor are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    AB Dental implants are designed to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing functions.
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    K Number
    K051719
    Device Name
    A.B. DENTAL DEVICES
    Manufacturer
    A.B. DENTAL DEVICES, LTD.
    Date Cleared
    2006-03-21

    (267 days)

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

    A.B. DENTAL DEVICES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A.B. Dental Devices' implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. Two-piece implants - I1, I2, I2b & I5: Two-stage implants - 12, 12b & 15 implants: Onc-stage implants -- 11 One piece implants - 16, 17 Implants for immediate loading when good primary stability is achieved and with appropriate occlusal loading - 12, 12b, 15, 16 & 17.
    Device Description
    Not Found
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