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510(k) Data Aggregation

    K Number
    K993136
    Date Cleared
    1999-10-21

    (31 days)

    Product Code
    Regulation Number
    872.3060
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    JEL BIOS 10 (CODE NAME RD-1801)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.

    Device Description

    High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.

    AI/ML Overview

    I am sorry, but since the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy, it does not contain information about the acceptance criteria and study details for a device's performance as would be found in a clinical study report. The letter confirms substantial equivalence to a predicate device but does not include the specifics of performance testing.

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