LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122852
    Device Name
    PHYSIOSTAR NFC
    Manufacturer
    CANDULOR USA, INC.
    Date Cleared
    2012-12-06

    (79 days)

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

    PHYSIOSTAR NFC

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

    Physiostar NFC denture teeth are intended to be used for complete and partial denture r nyslostar NF & dontare tooling and implant-supported dentures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Candulor USA, Incorporated, regarding their Physiostar NFC device, which is a preformed plastic denture tooth.

    The letter confirms the FDA's determination of substantial equivalence for the device based on its intended use, but it does not detail any performance studies, acceptance criteria, or specific performance metrics of the device itself. It mainly focuses on regulatory aspects and compliance requirements.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1