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510(k) Data Aggregation

    K Number
    K160867
    Device Name
    Pavati Z40.2 Zirconia
    Manufacturer
    Date Cleared
    2016-09-12

    (166 days)

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

    CCRI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Pavati® Z40.2 Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (crowns and bridges) in the anterior/ posterior applications. Pavati® Z40.2 Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use. Pavati® Z40.2 Zirconia blanks are for "Rx only" and not for use by the general public or sold as "Over- the-Counter".
    Device Description
    Pavati® Z40.2 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 patients 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 patients teeth as crowns or bridges.
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    K Number
    K151875
    Device Name
    Pavati Zirconia
    Manufacturer
    Date Cleared
    2015-10-29

    (112 days)

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

    CCRI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Pavati™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (crowns and bridges) in the anterior/ posterior applications. Pavati™ Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use. Pavati™ Zirconia blanks are for "Rx only" and not for use by the general public or sold as "Over-the-Counter".
    Device Description
    Pavati™ 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 patients 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 patients teeth as crowns or bridges.
    Ask a Question

    Ask a specific question about this device

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