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510(k) Data Aggregation

    K Number
    K071201
    Device Name
    ZEO CE LIGHT & ZEO QUICK PORCELAIN
    Manufacturer
    XPDENT CORP.
    Date Cleared
    2007-07-30

    (91 days)

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

    XPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Porcelain fused to metal for dental use.
    Device Description
    Not Found
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    K Number
    K061337
    Device Name
    WIEDENT ESTETIC
    Manufacturer
    XPDENT CORP.
    Date Cleared
    2006-06-07

    (26 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    XPDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.
    Device Description
    Not Found
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