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510(k) Data Aggregation

    K Number
    K213401
    Device Name
    DIAPLUS Universal
    Manufacturer
    Diadent Group International
    Date Cleared
    2022-01-31

    (105 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K161051
    Why did this record match?
    Device Name :

    DIAPLUS Universal

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. All direct restorations
      1. All indirect restorations
      1. Desensitizing/sealing of tooth
      1. Intra-oral repairs
    Device Description

    It is a 7th generation dentin adhesive system that handles all the functions of the conditioner primer bonding resin. The polymerization method is photopolymerization type, and after being applied to the tooth surface, the solvent is volatilized and polymerized in the drying process to perform the function as a dentine adhesive.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental resin bonding agent, DIAPLUS Universal (K213401). This submission aims to demonstrate substantial equivalence to a predicate device, ALL-BOND Universal w/BAC (K161051).

    However, this document does not contain information about an AI-powered medical device or software that would have "acceptance criteria" related to AI performance metrics like accuracy, sensitivity, specificity, or the results of a multi-reader multi-case (MRMC) study.

    Instead, the document focuses on demonstrating the substantial equivalence of a physical dental product (resin tooth bonding agent) through:

    • Comparison of Indications for Use, Composition, and Principle of Operation with a predicate device.
    • Non-clinical performance data which includes physical property tests (e.g., film thickness, shear bonding strength, sensitivity to light, occlusion of dentinal tubules) and biocompatibility tests (e.g., cytotoxicity, genotoxicity, irritation, systemic toxicity) conducted according to established international standards (ISO).
    • A statement that no clinical performance data was collected because it was not deemed necessary to demonstrate substantial equivalence for this type of device.

    Therefore, it is not possible to answer the request based on the provided text, as the document does not describe an AI medical device or a study proving its performance against AI-specific acceptance criteria.

    The questions in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set details) are relevant for AI/ML-based medical device submissions, but they do not apply to the traditional dental material device described in this specific FDA 510(k) clearance document.

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