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510(k) Data Aggregation

    K Number
    K250393
    Device Name
    ZircaGlow & ZircaGlow HT Zirconia
    Manufacturer
    United Zirconia
    Date Cleared
    2025-05-12

    (89 days)

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

    United Zirconia

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZircaGlow & ZircaGlow HT Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
    Device Description
    ZircaGlow & ZircaGlow HT Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as a crown, bridge or coping.
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