Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K960110
    Device Name
    KIS MT3
    Date Cleared
    1996-03-20

    (69 days)

    Product Code
    Regulation Number
    872.3640
    Panel
    Dental
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the programs and institute Moza Suite 302 for the patient.

    Device Description

    Endosseous implant system tools and consists of implants, This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving a device meets those criteria. The provided text is a 510(k) summary for dental implant components (abutments), focusing on demonstrating substantial equivalence to predicate devices. It describes the device, its intended use, and technological characteristics.

    Therefore, I cannot provide the requested table or answer the questions related to study design, sample sizes, ground truth establishment, or expert involvement.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1