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510(k) Data Aggregation

    K Number
    K053242
    Device Name
    PITT-EASY DENTAL IMPLANT SYSTEM
    Manufacturer
    INNOVA LIFE SCIENCES CORP.
    Date Cleared
    2006-01-06

    (49 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K961385,K983120
    Why did this record match?
    Reference Devices :

    K961385, K983120

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

    For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

    Device Description

    The Pitt-Easy™ Dental Implant System

    AI/ML Overview

    The provided document is a 510(k) summary for a dental implant system. It details the device's name, submitter, date prepared, predicate devices, intended use, principles of operation, and technological characteristics. The document explicitly states that the "minor modifications to the design of the Entegra™ Dental Implant System (K961385) and Bicortical® Screw Dental Implant System (K983120) do not alter the implant's fundamental scientific technology" and that the "modified device is substantially equivalent to the predicate devices."

    Therefore, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a declaration of substantial equivalence based on design and technological characteristics being identical or having minor modifications compared to previously cleared predicate devices, rather than performance data against specific acceptance criteria.

    Without any details on acceptance criteria or a performance study in the provided text, I cannot complete your request.

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