Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

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

    (246 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERIOSEAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1