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510(k) Data Aggregation

    K Number
    K192153
    Device Name
    Portux CAD/CAM Disc
    Manufacturer
    New Stetic S.A.
    Date Cleared
    2019-11-07

    (90 days)

    Product Code
    EBG, EBI, MQC
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    New Stetic S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics. - Provisional anterior and posterior crowns & bridges - Implant and abutment supported prosthetics. - Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint)
    Device Description
    The Subject device are discs made of poly methyl methacrylate (PMMA), a known material used in the dental field due their physical-chemical and biocompatibility properties. These discs are intended use with dental CAD/CAM equipment to produce a variety of provisional prosthetic restorations or devices. The discs are available in a variety of disc configurations to accommodate different commercial dental CAD/CAM machines fixture requirements. In addition, the CAD/CAM discs are available in a wide variety of heights and colors to facilitate matching of patient tooth or tissue shades.
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    K Number
    K140125
    Device Name
    NEW STETIC DENTAL AMALGAM ALLOY
    Manufacturer
    NEW STETIC
    Date Cleared
    2014-04-29

    (103 days)

    Product Code
    OIV, EJJ, ELY
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEW STETIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    New Stetic NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic Dental Amalgam Alloys are commonly used as a filling material for restoring the morphology and function of posterior teeth (cavities class I and II in molars and premolars), when these have lost their structure due to injuries such as cavities or fractures.
    Device Description
    New Stetic Dental Amalgam Alloys for dental amalgam used as a filling material for oral cavities. They are made of silver, tin and copper and free of zinc. The products are packaged in different forms: pre-dosed capsules, tablets and powder.
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    K Number
    K122925
    Device Name
    NEW STETIC ARTIFICIAL TEETH
    Manufacturer
    NEW STETIC
    Date Cleared
    2013-02-12

    (141 days)

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

    NEW STETIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.
    Device Description
    The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.
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    K Number
    K102874
    Device Name
    NEW STETIC ACRYLICS
    Manufacturer
    NEW STETIC
    Date Cleared
    2011-03-28

    (179 days)

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

    NEW STETIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use of the New Stetic® Acrtylics is for the repair or fabrication of the denture base.
    Device Description
    The product is a denture system consisting of monomer and polymer powder and liquid components.
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