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510(k) Data Aggregation

    K Number
    K961386
    Device Name
    MT-2A
    Manufacturer
    THE EMERGING TECHNOLOGIES GROUP
    Date Cleared
    1996-09-25

    (190 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K902433,K902434,K902435,K932123,K925766,K934826,K934495,K933969,K934126,K933462
    Why did this record match?
    Device Name :

    MT-2A

    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 prosthesis for for the patient.

    Device Description

    Endosseous implant system consists of implants, tools and 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 is a 510(k) summary for a medical device submitted in 1996. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study data for a new device's performance.

    Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. This document is a regulatory submission for pre-market notification, not a clinical study report.

    The 510(k) summary outlines:

    • Predicate Devices: Lists previously cleared devices that the current device claims substantial equivalence to.
    • Device Description: Briefly describes the endosseous implant system, including implants, tools, and particularly pre-machined angulated abutments (15 and 25 degrees) and wide-body abutments (4, 5, and 6 mm platform diameters).
    • Intended Use: To facilitate the prosthetic phase and installation of prostheses.
    • Technology Characteristic Summary: States that design, material, manufacturing process, sterilization, geometry, and materials are similar to predicate devices. It specifies the use of ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5, and mentions GMP compliance.

    Without a clinical study report or a different type of technical document, it's impossible to provide the requested details about acceptance criteria and device performance as these are not part of a standard 510(k) summary.

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