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510(k) Data Aggregation

    K Number
    K982129
    Device Name
    ANTAGON PORCELAIN
    Date Cleared
    1998-08-04

    (48 days)

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

    EUROPEAN DENTAL IMPORTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis. Antagon Porcelain is recommended for use with any normalfusing-temperature dental ceramic alloy. After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.
    Device Description
    Antagon Porcelain
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    K Number
    K981001
    Device Name
    ORION VESTA DENTAL ALLOY
    Date Cleared
    1998-05-18

    (61 days)

    Product Code
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROPEAN DENTAL IMPORTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, and attachments; precious metal copings and bridges for porcelain-fusedto-metal restorations. Orion Vesta is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
    Device Description
    Orion Vesta Dental Alloy
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    K Number
    K981002
    Device Name
    ORION WX DENTAL ALLOY
    Date Cleared
    1998-05-18

    (61 days)

    Product Code
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROPEAN DENTAL IMPORTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, and attachments; precious metal copings and bridges for porcelain-fusedto-metal restorations. Orion WX is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
    Device Description
    Orion WX Dental Alloy
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    K Number
    K981000
    Device Name
    CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
    Date Cleared
    1998-05-15

    (58 days)

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

    EUROPEAN DENTAL IMPORTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis. Carrara Porcelain and Carrara Vincent Porcelain are recommended for use only with Carrara and Cera E dental alloys. After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.
    Device Description
    Carrara Porcelain and Carrara Vincent Porcelain
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    K Number
    K980661
    Device Name
    CERA E DENTAL ALLOY
    Date Cleared
    1998-05-01

    (70 days)

    Product Code
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROPEAN DENTAL IMPORTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, and attachments; precious metal copings and bridges for porcelain-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Cera E alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
    Device Description
    Cera E Dental Alloy
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    K Number
    K980660
    Device Name
    BIOGOLD PLUS DENTAL ALLOY
    Date Cleared
    1998-04-27

    (66 days)

    Product Code
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROPEAN DENTAL IMPORTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal bridges, bars, and posts; precious metal copings, pontics and bridges for porcelain-fused-to-metal restorations. For porcelain-fused-to-metal restorations it is intended by the manufacturer that only normal-fusing-temperature porcelain products be used with the Biogold Plus alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
    Device Description
    Biogold Plus Dental Alloy
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    K Number
    K980597
    Device Name
    CARRARA PDF, CARRARA H, CARRARA R
    Date Cleared
    1998-03-09

    (20 days)

    Product Code
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROPEAN DENTAL IMPORTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, posts, and attachments; precious metal copings and bridges for porcelain-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Carrara alloys. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
    Device Description
    Not Found
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