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510(k) Data Aggregation

    K Number
    K250123
    Device Name
    Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
    Manufacturer
    Hager & Meisinger GmbH
    Date Cleared
    2025-09-29

    (255 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K093719
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Master Pin X (MP Pins with thread) are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow the fixation of resorbable, non-resorbable and titanium-reinforced membranes in the dense cortical bone

    Device Description

    The Master-Pins X have been developed especially for the fixation of membranes. The pins are made of grade 5 titanium alloy and have a self-drilling thread that allows them to be inserted into the cortical bone. They have a total length of 3.2 mm and a declining thread diameter, with a maximum of 1.45 mm thread diameter.

    AI/ML Overview

    N/A

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