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510(k) Data Aggregation

    K Number
    K965032
    Device Name
    THE PERIOSEAL DENTAL IMPLANT
    Manufacturer
    PERIOSEAL
    Date Cleared
    1997-08-20

    (246 days)

    Product Code
    DZE
    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

    Indications for use: The PerioSeal® dental implant is intended to be surgically implanted into the edentulous areas of the mandible or maxilla to serve as support for a dental prosthesis. This device is intended for the treatment of edentulism in the totally or partially edentulous population, but limited to those individuals who are suitable candidates for the surgical and prosthetic procedures. The PerioSeal® dental implant is intended for use in the mandible or maxilla as an artificial root structure for replacement of a single tooth or as an abutment for retention of bridgework or dentures of various configurations. This device is intended for sale to or use on the order of a licensed dentist of physician.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental implant called "PerioSeal Dental Implant". It indicates that the device has been found substantially equivalent to predicate devices. However, this letter does not contain any information regarding acceptance criteria, study details, or performance data for the device.

    Therefore, I cannot provide the requested information. The document is solely a clearance notification, not a study report or a detailed performance and acceptance criteria document.

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