LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181157
    Device Name
    Conical Plus Implant System
    Manufacturer
    OsseoFuse International, Inc.
    Date Cleared
    2019-05-24

    (388 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Conical Plus Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, In support of single or multiple-unit retained, screw-retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. The systems is intended for delayed loading.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested. This document is a 510(k) clearance letter from the FDA for a dental implant system. It outlines the regulatory classification, general controls, and other requirements for the device. However, it does not describe any acceptance criteria, performance studies, or details about artificial intelligence (AI) or machine learning (ML) components.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1