LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K112168
    Device Name
    COMPONEER
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2011-11-21

    (116 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K191385
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • -restoration therapy for caries
    • -optimisation of old restorations
    • -tooth fractures
    • -extending incisors
    • -malpositioned teeth
    • -tooth discoloration, incorrect shading
    • -anatomical malformation
    • -diasteme
    • -attrition, abrasion, erosion
    • -cosmetic correction
    Device Description

    COMPONEER are polymerised, radio-opaque composite shells

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding a dental device called COMPONEER. It does not contain information about the acceptance criteria or a study proving the device meets said criteria for an AI/ML powered medical device.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination based on comparing the new device to existing ones, rather than through a study with specified acceptance criteria for algorithm performance.

    Therefore, I cannot extract the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1