LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061264
    Device Name
    TEMPFX ESTHETIC PROVISIONAL SYSTEM
    Manufacturer
    DENTSPLY INTERNATIONAL, INC.
    Date Cleared
    2006-05-23

    (18 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K904251
    Why did this record match?
    Device Name :

    TEMPFX ESTHETIC PROVISIONAL SYSTEM

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

    TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional dental restorations.

    Device Description

    The TEMPFX ESTHETIC PROVISIONAL SYSTEM includes visible light cured resin based composites and accessories used to create provisional restorations for patients awaiting final prosthodontic restoration.

    AI/ML Overview

    The provided text is a 510(k) summary for the DENTSPLY TEMPFX ESTHETIC PROVISIONAL SYSTEM. This document focuses on the regulatory submission for a dental material and does not contain information about acceptance criteria, device performance from a study, or any details related to AI/algorithm performance.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies, as they are not present in the provided text.

    The document primarily covers:

    • Contact information and submission date.
    • Trade name, classification name, and predicate device.
    • Device description and intended use.
    • Claim of substantial equivalence to predicate devices based on component use and biocompatibility testing.
    • FDA's letter of clearance and confirmation of substantial equivalence.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1