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510(k) Data Aggregation

    K Number
    K201683
    Device Name
    PMMA Block
    Manufacturer
    Huge Dental Material Co., Ltd.
    Date Cleared
    2020-11-03

    (134 days)

    Product Code
    EBG,EBI,MQC
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K141421,K101029
    Why did this record match?
    Reference Devices :

    K141421

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

    PMMA BLOCK particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM.

    Indications for Use:

    • Temporary anterior and posterior crowns;
    • Temporary anterior and posterior bridges;
    • Implant surgical guide;
    • Removable structures for dentures;
    • Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
    Device Description

    PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.

    PMMA BLOCK are made with the same material (Hot cured PMMA) that is used for the manufacture of the HUGE Synthetic Polymer Teeth (K101029) and HUGE PMMA Block(K141421). These polymer discs or blocks are especially suited for creating dental structures by means of milling CAD/CAM techniques commonly used in the dental laboratories and in dental practice. The elaboration is designed by a professional, a dental technician or a dentist. This guarantees their correct use, since it is an intermediate product in order to manufacture a custom-made product.

    AI/ML Overview

    The provided text is a 510(k) summary for the PMMA Block, a dental material. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

    However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI or machine learning performance. The "acceptance criteria" discussed in the document pertain to the physical and chemical properties of the PMMA Block and its compliance with ISO standards for dental materials.

    Therefore, I cannot provide the requested information regarding:

    • A table of acceptance criteria for AI performance and reported device performance.
    • Sample sizes, data provenance, number of experts for ground truth, adjudication methods for a test set.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • Type of ground truth used related to AI.
    • Training set sample size or how ground truth for training was established.

    The document focuses on the material's properties, chemical composition, and manufacturing process, asserting substantial equivalence to existing dental materials, not on the performance of an AI-powered device.

    Summary of relevant information from the document (not directly answering the AI-related questions):

    • Device: PMMA Block (dental polymer blanks)
    • Purpose: For making removable or temporary dental structures (crowns, bridges, surgical guides, dentures, night guards/bite splints) using CAD/CAM milling.
    • Study Type: This is a 510(k) premarket notification based on substantial equivalence to predicate devices, not a clinical performance study of a novel AI or medical imaging device.
    • "Acceptance Criteria" presented: Primarily physical and chemical properties of the material, tested against ISO standards (ISO 10477, ISO 20795-1, ISO 22112).
      • Flexural strength: The new device must meet $\ge$ 50 MPa (ISO 10477) and $\ge$ 65 MPa (ISO 20795-1).
      • Water absorption: The new device must meet $\le$ 0.040 mg/mm³ (ISO 10477) and $\le$ 0.032 mg/mm³ (ISO 20795-1).
      • Water solubility: The new device must meet $\le$ 0.0075 mg/mm³ (ISO 10477) and $\le$ 0.0016 mg/mm³ (ISO 20795-1).
      • Residual monomer content: The new device must meet $\le$ 2.2% (ISO 20795-1).
      • Dimensional stability: The new device must meet within ± 2% of original mesio-distal dimension (ISO 22112).
    • Reported Device Performance (from Table 4):
      • Flexural strength: $\ge$ 50 MPa and $\ge$ 65 MPa (meeting the criteria).
      • Water absorption: $\le$ 0.040 mg/mm³ and $\le$ 0.032 mg/mm³ (meeting the criteria).
      • Water solubility: $\le$ 0.0075 mg/mm³ and $\le$ 0.0016 mg/mm³ (meeting the criteria).
      • Residual monomer content: $\le$ 2.2% (meeting the criteria).
      • Dimensional stability: 0.29% (meeting the criteria of ± 2%).
    • Biocompatibility: Tests were performed according to ISO 10993 standards (Systemic Toxicity, Irritation, Sensitization, Cytotoxicity, In Vitro Mammalian Cell TK Gene Mutation Test, In Vitro mammalian chromosome aberration test, and Bacterial reverse mutation study). The document states the device is "Non cytotoxic."
    • Clinical Performance Data: "Not applicable. Clinical performance testing has not been performed for the subject device." (Section 10).
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