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510(k) Data Aggregation

    K Number
    K962610
    Device Name
    DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES
    Manufacturer
    IMPLANT INTEGRATION SYSTEMS, INC.
    Date Cleared
    1996-10-18

    (107 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K902434,K903062,K874590,K904709
    Why did this record match?
    Reference Devices :

    K902434,K903062,K874590

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

    The "Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a "Summary of Safety and Effectiveness Information" for a dental implant accessory ("Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver) from Implant Integration Systems, Inc., dated October 18, 1996.

    This document does not contain any information regarding acceptance criteria, device performance, clinical study design, sample sizes, expert involvement, or any of the other specific details requested in your prompt.

    It is a regulatory submission describing the product and its similarity to other existing devices, rather than a report on clinical trial results or performance studies.

    Therefore,Based on the provided document, I cannot fulfill your request as it does not contain the necessary information to describe the acceptance criteria and the study that proves the device meets them.

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