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510(k) Data Aggregation

    K Number
    K143656
    Device Name
    StarCeram® Z-Nature, StarCeram® Z-Smile
    Manufacturer
    H.C. Starck Ceramics GmbH
    Date Cleared
    2015-07-09

    (198 days)

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

    H.C. Starck Ceramics GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Blanks made from StarCeram® Z-Nature are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges. Dental Blanks made from StarCeram® Z-Smile are indicated for crowns and bridges, multi-unit bridges, inlay bridges and all-ceramic restoration as max three-unit bridge at the anterior and posterior area.
    Device Description
    Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling. StarCeram® Z-Smile and StarCeram® Z-Nature are a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213 and K140924. StarCeram® Z-Smile and StarCeram® Z-Nature have the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change between the cleared products and the new products is the addition of new color qualities.
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    K Number
    K140924
    Device Name
    STARCERAM
    Manufacturer
    H.C. STARCK CERAMICS GMBH
    Date Cleared
    2014-06-05

    (55 days)

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

    H.C. STARCK CERAMICS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
    Device Description
    Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling. StarCeram® Z-Med TransColour Red is a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213. StarCeram® Z-Med TransColour Red has the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change is the addition of a new color additive.
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    K Number
    K133213
    Device Name
    STARCERAM
    Manufacturer
    H.C. STARCK CERAMICS GMBH
    Date Cleared
    2013-12-05

    (48 days)

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

    H.C. STARCK CERAMICS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
    Device Description
    Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling.
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    K Number
    K081263
    Device Name
    STARCERAM
    Manufacturer
    H.C. STARCK CERAMICS GMBH & CO.KG
    Date Cleared
    2008-07-01

    (57 days)

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

    H.C. STARCK CERAMICS GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
    Device Description
    Dental blanks made of StarCeram® Z-Med or StarCeram® Z-AI-Med HD are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or handoperated copy-milling machines, with outstanding biocompatibility and high resistance against tension and pressure.
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