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510(k) Data Aggregation

    K Number
    K241673
    Device Name
    Denture Base Resin (PN-Denture (Red, White))
    Manufacturer
    Shenzhen Piocreat 3D Technology Co., Ltd.
    Date Cleared
    2024-10-15

    (126 days)

    Product Code
    EBF,EBG,EBI,ELM,PZY
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K210977,K220771
    Why did this record match?
    Device Name :

    Denture Base Resin (PN-Denture (Red, White))

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

    Denture Base Resin is a light-curable resin indicated for the fabrication of:
    •individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area
    •denture bases
    Denture Base Resin is intended exclusively for professional dental work.

    Device Description

    The Denture Base Resin is an alternative to traditional heat cured and auto polymerization resins. The resins are available in two (2) different colors ( white, red). Denture Base Resin can be used with PioNext D Series. PioNext D Series printers include a 3D printing system that utilizes Digital Light Process (DLP) technology, with automatic feeding process, and a UV LED (405nm) curing process. The dental appliance is then cured in the PioNext UV-02 curing chamber and sent back to the dentist for try-in and final adjustment.

    AI/ML Overview

    I'm sorry, but this document does not contain the information required to answer your request. The provided text is a 510(k) premarket notification letter from the FDA regarding a "Denture Base Resin" device.

    It does not provide details about acceptance criteria or a study proving that an AI/software-based device meets these acceptance criteria. Instead, it focuses on dental resin material properties and non-clinical performance tests, not AI or software performance.

    Therefore, I cannot provide:

    • A table of acceptance criteria and reported device performance for an AI/software.
    • Sample sizes used for test sets or data provenance for AI/software.
    • Number of experts or their qualifications for establishing ground truth for AI/software.
    • Adjudication methods for AI/software test sets.
    • Information about MRMC comparative effectiveness studies or effect sizes for AI assistance.
    • Standalone performance of an AI algorithm.
    • Type of ground truth for an AI/software.
    • Sample size for training sets for an AI/software.
    • How ground truth was established for training sets for an AI/software.

    The document discusses "Denture Base Resin" and its properties, and confirms its substantial equivalence to predicate devices based on non-clinical performance tests related to dimensional stability, color stability, translucency, flexural strength, freedom from porosity, and water solubility. There is no mention of AI, machine learning, or software performance evaluation in this context.

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