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510(k) Data Aggregation

    K Number
    K082137
    Device Name
    DLMS-ZIRBLOCKS
    Date Cleared
    2009-02-10

    (196 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAL MILLING LABORATORY SUPPLIES (DLMS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration.
    Device Description
    DLMS-Zirblocks is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is capable of machining by modern methods. The material is designated as TZP (slightly stronger) or TZPA (slightly more translucent). The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods, sintered to full density, and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or only in place with standard dental adhesives (luting) materials. The material is radio-opaque, for ready visualization.
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