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510(k) Data Aggregation

    K Number
    K091362
    Device Name
    CERAMIC PEDATRIC PREFORMED CROWN
    Manufacturer
    Date Cleared
    2009-06-29

    (52 days)

    Product Code
    Regulation Number
    872.3330
    Why did this record match?
    Product Code :

    ELZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is intended to be used as a functional restoration for primary teeth, including for a badly decayed deciduous (baby) tooth, until the adult tooth erupts. It is not intended for permanent restoration. The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is indicated for use in infants, children, and adolescents.
    Device Description
    The EPI Ceramic Pediatric Preformed Crown is a temporary tooth restoration. The dental crown is a tooth-shaped "cap" that is placed over a tooth - covering the tooth to restore its shape and size, strength, and/or to improve its appearance. The preformed crowns are manufatured in specific sizes for a proper fit, which are contained within the range of sizes commonly available for existing preformed crowns. Sizing is exclusively determined by the dentist for their particular patient and the EPI crowns are not meant to undergo further manipulation by the dentist. The EPI Ceramic Pediatric Preformed Crown is secured within the patient's mouth using standard denal adhesion techniques. The crowns, when cemented into place, fully encase the entre visible portion of a tooth that lies at and above the gum line. The EPI Ceramic Pediatric Preformed Crown is made of Zirconia. Zirconia is a biologically inert, high-tech ceramic material (dental porcelain) intended for use in the construction of irentium oxide ceramic prosthetics. Because the EPI crowns are distributed in their final, finished form, there are no pellets, casting alloys, powders or auto mix systems that require firther manipulation by the dentist.
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