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510(k) Data Aggregation

    K Number
    K011674
    Device Name
    DC - CRISTAL
    Manufacturer
    AUSTENAL, INC.
    Date Cleared
    2001-09-04

    (97 days)

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

    AUSTENAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use for DC-Cristall is as a substructure for single unit porcelain fused ceramic fixed dental restorations; namely crowns. Substructures of DC-Cristall are machined using the DCS Precident CAD/CAM System.
    Device Description
    The DC-Cristall material is a glass ceramic material, furnished in a block form, designed for use as feed stock in the DCS Precident CAD/CAM System.
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    K Number
    K001799
    Device Name
    DC-TELL
    Manufacturer
    AUSTENAL, INC.
    Date Cleared
    2000-08-10

    (57 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUSTENAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001815
    Device Name
    DC ZIRKON
    Manufacturer
    AUSTENAL, INC.
    Date Cleared
    2000-08-10

    (56 days)

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

    AUSTENAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001798
    Device Name
    DC TITAN
    Manufacturer
    AUSTENAL, INC.
    Date Cleared
    2000-07-31

    (47 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUSTENAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970522
    Device Name
    MYERSON'S ECONOMY DENTURE BASE MATERIAL
    Manufacturer
    AUSTENAL, INC.
    Date Cleared
    1997-05-14

    (92 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUSTENAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Myerson Economy Denture Base Material is intended for use in the fabrication of full and partial dentures.
    Device Description
    The Myerson Economy Denture Base Material is a conventional dough pack heat cure denture base material that consists of a polymethyl methacrylate polymer powder with a heat cure monomer consisting of methyl methacrylate, crosslinker (either EGDMA or TEGDMA), 0-1% UV Light Absorber. The polymer is shaded to simulate the color of gum tissue using pigments that appear on the FDA list of approved products.
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    K Number
    K970205
    Device Name
    VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY
    Manufacturer
    AUSTENAL, INC.
    Date Cleared
    1997-04-21

    (90 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUSTENAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The above name products are intended for use as base metal casting alloys for casting removable partial denture frameworks.
    Device Description
    The family of Base Metal Casting Alloys are cobalt chrome casting alloys substantially equivalent to the alloys currently used to produce partial denture frameworks.
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