LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K240714
    Device Name
    Insure® Universal; Insure® Universal Automix
    Manufacturer
    Cosmedent Inc.
    Date Cleared
    2024-07-24

    (131 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Insure**®** Universal; Insure**®** Universal Automix

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

    Insure® Universal
    Cementation of ceramic and composite veneers, inlays and onlays with a thickness

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a dental cement product (Insure® Universal; Insure® Universal Automix).

    This letter primarily focuses on:

    • Device Clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
    • Regulatory Information: Details about regulations (e.g., 21 CFR 872.3275 for Dental Cement, Quality System regulation 21 CFR Part 820), responsibilities of the manufacturer (listing, labeling, adverse event reporting, good manufacturing practices), and guidance documents.
    • Indications for Use: What the dental cement is intended to be used for (e.g., cementation of ceramic and composite veneers, inlays, onlays, crowns, and bridges).

    There is no mention of specific performance metrics, acceptance criteria tables, study designs (sample sizes, retrospective/prospective, number of experts, adjudication methods, MRMC studies, standalone performance), or how ground truth was established for any AI or software-related device. The product mentioned is a physical dental cement, not an AI software or a device that would typically involve the types of studies you are asking about (like imaging devices with AI assistance).

    Therefore, I cannot fulfill your request based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1