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510(k) Data Aggregation

    K Number
    K031877
    Device Name
    EMBRACE WET-BOND RESTORATIVE MATERIAL
    Manufacturer
    PULPDENT CORPORATION
    Date Cleared
    2003-08-01

    (45 days)

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

    EMBRACE WET-BOND RESTORATIVE MATERIAL

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

    Embrace™ Wet-Bond Restorative Material is a hydrophilic, fluoride-releasing, light-cured material recommended for use as a tooth replacement material. Applications of Embrace™ Wet-Bond Restorative Material include: Class I, III, IV, and V cavity preparations and as a restorative material for small incipient lesions.

    Device Description

    Embrace™ Wet-Bond Restorative Material is a hydrophilic, fluoride-releasing, light-cured material recommended for use as a tooth replacement material.

    AI/ML Overview

    This document (K031877) describes the Embrace™ Wet-Bond Restorative Material, a dental restorative material. The information provided heavily emphasizes substantial equivalence to predicate devices rather than independent performance testing against specific acceptance criteria. Therefore, several requested categories regarding device performance and study design are not explicitly detailed in the provided text.

    Here's the breakdown based on the provided information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryAcceptance CriteriaReported Device Performance
    Material PropertiesSubstantially equivalent in physical and mechanical properties to predicate products"laboratory testing has shown that Embrace™ Wet-Bond Restorative Material is physical and mechanical properties to the predicate products." (The specific properties and exact equivalence metrics are not detailed.)
    Safety and EffectivenessSubstantially equivalent to predicate products, which have a high benefit-to-risk ratio"Embrace™ Wet-Bond Restorative Material is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above."
    Intended UseAs a tooth replacement material for Class I, III, IV, and V cavity preparations and small incipient lesions"Embrace™ Wet-Bond Restorative Material is a hydrophilic, fluoride-releasing, light-cured material recommended for use as a tooth replacement material. Applications... include: Class I, III, IV, and V cavity preparations and as a restorative material for small incipient lesions."

    2. Sample Size Used for the Test Set and Data Provenance

    • Not explicitly stated. The document mentions "laboratory testing" regarding physical and mechanical properties, but details about the sample size of materials tested or the origin of any patient/clinical data (retrospective/prospective, country of origin) are absent. This 510(k) submission largely relies on comparative claims rather than de novo clinical trial data.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    • Not applicable. This submission focuses on material properties and chemical composition compared to predicate devices, not on a diagnostic or screening device that requires expert ground truth establishment for a test set. There's no mention of experts establishing ground truth for performance.

    4. Adjudication Method for the Test Set

    • Not applicable. As above, there is no mention of a diagnostic test set requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    • No. This is a submission for a dental restorative material, not an AI-assisted diagnostic tool typically evaluated with MRMC studies.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    • Not applicable. This is a material, not an algorithm.

    7. The Type of Ground Truth Used

    • For material properties: The implicit "ground truth" seems to be the established performance and safety profiles of the predicate devices (e.g., Ivoclar Tetric Flow, Ivoclar Compoqlass Flow) as determined by their own prior testing and market acceptance.
    • For safety and effectiveness: The "NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials" is cited, indicating that the general class of materials (composites and glass ionomers) has a "high benefit-to-risk ratio" and is "relatively trouble-free," serving as a broader contextual ground truth for the safety of similar dental materials.

    8. The Sample Size for the Training Set

    • Not applicable. This is a medical device material, not an AI algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. This is a medical device material, not an AI algorithm that requires a training set.
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