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510(k) Data Aggregation

    K Number
    K100411
    Device Name
    VARIOUS DENTAL IMPLANTS
    Manufacturer
    GRUNDY ADVANCED BIOMEDICAL SYSTEMS LLC
    Date Cleared
    2010-07-28

    (162 days)

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

    GRUNDY ADVANCED BIOMEDICAL SYSTEMS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THE IMPLANT(S) IS DESIGNED FOR USE IN THE EDENTULOUS SITES IN THE MANDIBLE OR MAXILLA FOR SUPPORT OF A COMPLETE DENTURE PROSTHESIS, A TERMINAL OR INTERMEDIATE ABUTMENT FOR FIXED OR PARTIAL DENTURES, OR A SINGLE TOOTH REPLACEMENT. THE 8,25MM LONG IMPLANT CAN NOT BE USED AS A SINGLE TOOTH REPLACEMENT.
    Device Description
    Not Found
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