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510(k) Data Aggregation

    K Number
    K101044
    Manufacturer
    Date Cleared
    2010-06-10

    (57 days)

    Product Code
    Regulation Number
    872.3275
    Panel
    Dental
    Reference & Predicate Devices
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    Device Name :

    RETRIEVE IMPLANT CEMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RETRIEVE Implant Cement is a resin-based, self-curing, dual-component dental cement. It is intended for mid- to long-term (semi-permanent) cementation of porcelain, ceramic, resin, and metal-based dental prostheses to dental implants, while allowing retrieval of the prostheses, if necessary. Retrieve can also be used as a temporary filling material.

    Device Description

    RETRIEVE is an acrylate- and methacrylate-based resin cement for semi-permanent cementation of porcelain, ceramic, resin and metalbased dental prostheses to dental implants. The cement is not considered fully "permanent," and is therefore substantially equivalent to temporary cements, because its bond strength is high enough to maintain the prosthesis in place during normal wear, but low enough to allow for removal by a dental professional for maintenance, replacement, and/or hygienic cleaning. RETRIEVE Implant Cement is a resin-based, self-curing, dual-component dental cement. RETRIEVE dental implant cement is a two-part cement and is typically supplied in a double-barrel, auto-mix syringe. The cement system does not require acid etching of tooth surfaces, and self-cures.

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