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510(k) Data Aggregation

    K Number
    K223182
    Device Name
    Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy
    Manufacturer
    WorldWork S.R.L
    Date Cleared
    2023-05-01

    (202 days)

    Product Code
    OIV, EJJ
    Regulation Number
    872.3070
    Why did this record match?
    Product Code :

    OIV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Filling material as a treatment for dental caries
    Device Description
    The subject devices are a mixture (alloy) of silver and several other metals, used by dentists to make fillings for tooth cavities. Amalgam alloys have been the most commonly used direct restorative filling material for over a 100 years.
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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?
    Product Code :

    OIV

    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
    K081273
    Device Name
    ULTRACAPS S
    Manufacturer
    SDI LTD.
    Date Cleared
    2008-07-10

    (66 days)

    Product Code
    OIV, EJJ, ELY
    Regulation Number
    872.3070
    Why did this record match?
    Product Code :

    OIV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for tooth restorations as a treatment for dental carries and for interious for tooth restorations (Class I and Class II), when other materials or restoration techniques are not indicated. For professional use only.
    Device Description
    Not Found
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