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510(k) Data Aggregation

    K Number
    K250302
    Device Name
    Flexible Partial Resin
    Manufacturer
    Prismatik Dentalcraft, Inc.
    Date Cleared
    2025-06-25

    (142 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K223798,K213994
    Why did this record match?
    Reference Devices :

    K223798

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

    Flexible Partial Resin is indicated for the fabrication of dental appliances such as dental plates, bite plates, partial denture frame-works and clasps.

    Device Description

    The subject device, Flexible Partial Resin, is a light-cured polymerizable resin for the fabrication of partial removable denture bases made in dental laboratories. The resin can be used in DLP printers utilizing a wavelength of 385nm and will be offered in G1 (standard pink), G3 (medium pink), and G4 (dark pink) shades formulated to match gingival tissue. The final medical device is a custom fitted appliance that is compliant to the dental professional's diagnosis and prescription.

    AI/ML Overview

    The provided document is a 510(k) clearance letter for a dental resin, not a study report for an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and studies for device performance as it pertains to an AI/ML device.

    The document discusses the substantial equivalence of a new dental resin (Flexible Partial Resin) to a predicate device (Flexible Block) based on:

    • Indications for Use Comparison: Both devices are indicated for fabricating dental appliances such as dental plates, bite plates, partial denture frameworks, and clasps. The predicate has additional indications not claimed by the subject device.
    • Technological Comparison: The devices are compared based on material composition and principle of operation. The subject device uses a methacrylate/dimethacrylate-based resin and 3D printing (DLP), while the predicate uses polyamide and milling from blocks.
    • Performance Testing: Non-clinical tests were conducted to compare the physical properties of the subject device to the predicate device using ASTM standards (Flexural Strength and Modulus, Tensile Strength, Elongation at Break, Impact Strength, Water Absorption). Printing accuracy was also tested.
    • Biocompatibility: The subject device was evaluated per ISO 10993-1:2018, leveraging data from a reference device.

    Key takeaway for your request:

    The FDA 510(k) clearance letter for "Flexible Partial Resin" does not describe an AI/ML device or a study involving AI/ML performance. Therefore, it does not contain information about:

    • Acceptance criteria and performance for an AI/ML device.
    • Sample sizes for test sets, data provenance, or ground truth establishment relevant to AI/ML.
    • Number of experts, adjudication methods, MRMC studies, or standalone algorithm performance for AI/ML.
    • Training set size or ground truth for an AI/ML model.

    This document is for a material used in dental device fabrication, not an AI-powered diagnostic or assistive tool.

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