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510(k) Data Aggregation

    K Number
    K093331
    Device Name
    SR PHONARES NHC
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2010-01-28

    (94 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SR PHONARES NHC

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

    SR Phonares NHC denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to Ivoclar Vivadent, Incorporated, for a dental device called "SR PHONARES NHC," which is a preformed plastic denture tooth. This document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

    The letter is a regulatory approval document stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It discusses general control provisions, regulatory classifications, and reporting requirements, but it does not detail any performance studies, test results, or acceptance criteria the manufacturer may have used to demonstrate substantial equivalence to the FDA.

    Therefore, I cannot provide the requested information based on the given input.

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