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510(k) Data Aggregation

    K Number
    K151699
    Date Cleared
    2015-12-10

    (169 days)

    Product Code
    Regulation Number
    872.3690
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BEAUTIFIL II Enamel

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

    BEAUTIFIL II Enamel is a light-cured radiopaque restorative material, designed for anterior restorations as well as posterior restorations including for restorations involving occlusal surfaces. It can also be used for repair of restorations and prostheses.
    (Indications)
    · Direct anterior and posterior restorations (except for tooth root)
    · Repair of restorations and prostheses

    Device Description

    BEAUTIFIL II Enamel is a light-cured radiopaque restorative material.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental restorative material, not an AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies typically associated with AI/ML device evaluations.

    The document mainly focuses on:

    • Device Name: Beautifil II Enamel
    • Regulation Number: 21 CFR 872.3690
    • Regulation Name: Tooth shade resin material
    • Regulatory Class: II
    • Product Code: EBF
    • Indications for Use: Direct anterior and posterior restorations (except for tooth root), and repair of restorations and prostheses.
    • FDA Determination: Substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information for acceptance criteria and study data because this document pertains to a traditional medical device (dental filling material) and does not involve AI/ML technology or associated performance studies in the context of diagnostic or prognostic capabilities.

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