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510(k) Data Aggregation

    K Number
    K032263
    Device Name
    3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
    Manufacturer
    IMPLANT INNOVATIONS, INC.
    Date Cleared
    2004-01-28

    (189 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K980083,K965077,K962465,K932123,K933462,K933969,K934126,K891613,K871863,K974150,K981858,K012911,K991947
    Why did this record match?
    Reference Devices :

    K980083, K965077, K962465, K932123, K933462, K933969, K934126, K891613, K871863, K974150, K981858

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

    The 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

    Device Description

    The 3i Patient-Specific Dental Abutments and Overdenture Bars are designed to match individual patients.

    AI/ML Overview

    This is a 510(k) premarket notification for a dental device, not an AI/ML medical device. As such, the document does not contain the information required to answer the questions regarding acceptance criteria and studies that prove the device meets them in the context of AI/ML performance.

    The document primarily focuses on establishing substantial equivalence to predicate devices based on overall design and intended use, rather than presenting a performance study with acceptance criteria for an AI algorithm.

    Therefore, most of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI) is not applicable or present in this submission.

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