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510(k) Data Aggregation

    K Number
    K061335
    Device Name
    ENHANCE DENTAL IMPLANT SYSTEM
    Manufacturer
    Date Cleared
    2006-08-09

    (89 days)

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

    COASTAL BIOCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Enhance Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. It may be placed immediately in an extraction site or may be placed after bone healing.
    Device Description
    The Enhance Dental Implant System (Enhance System) is a system of threaded root-form dental implants and abutments.
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