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510(k) Data Aggregation

    K Number
    K080713
    Manufacturer
    Date Cleared
    2008-05-16

    (64 days)

    Product Code
    Regulation Number
    872.3640
    Panel
    Dental
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    REACTIVE DENTAL IMPLANT SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ReActive Dental Implant System are dental implant fixtures that are a part of a two-piece implant system. The ReActive implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

    Device Description

    The ReActive Implant system consists of tapered screw-type endosseous implants with the same standard thread configuration, the same 2mm of minithreads near the top of each implant, are manufactured using the same medical grade titanium alloy material and are textured with the same soluble blast media (SBM)

    AI/ML Overview

    Please provide the content of the study or details of the acceptance criteria and performance, as the provided text is a 510(k) summary for a dental implant system and indicates the device is substantially equivalent to predicate devices, but does not contain information about acceptance criteria, performance studies, sample sizes, or expert involvement. The document primarily focuses on the device's description, intended use, and comparison to predicate devices for regulatory clearance.

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