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510(k) Data Aggregation

    K Number
    K220042
    Device Name
    Dentca Base Premium, Dentca Base Hi-Impact
    Manufacturer
    Dentca, Inc.
    Date Cleared
    2022-11-17

    (316 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K160244,K190043
    Why did this record match?
    Device Name :

    Dentca Base Premium, Dentca Base Hi-Impact

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

    DENTCA Base Resin is a light-curable resin indicated for the fabrication and repair of removable denture bases in dental laboratories, including full and partial dentures as well as immediate dentures, and baseplates. DENTCA Base Resin can also be used for the fabrication of try-in dentures for the evaluation before fabricating the final dentures. Fabrication of these prostheses with DENTCA Base Resin requires a digital denture file, additive printer, and curing light equipment. DENTCA Base Resin can be utilized as an aid in bonding the denture teeth onto denture base.

    Device Description

    DENTCA Base Resin is a light-curable resin intended to fabricate removable dentures in a CAD/CAM system using an additive printing process. This material is used as an alternative to traditional heat cured and auto polymerizing denture base resins and is available in multiple shades. DENTCA Base Resin can also be utilized to repair the printed denture and to bond printed teeth onto denture base.

    AI/ML Overview

    The provided text does not contain information about an AI/ML powered device, but rather a dental resin material. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets these criteria for an AI/ML device.

    The document is a 510(k) premarket notification for a dental resin called "DENTCA Base Resin," which is a light-curable resin for fabricating and repairing removable denture bases. The "Performance Data" section discusses:

    • Biocompatibility Testing: Conducted according to ISO 7405:2018 and FDA Guidance for medical devices in dentistry.
    • Software Verification and Validation Testing: For the additive printing (3D printer) operation software, in accordance with FDA guidance for "Off-The-Shelf Software Use in Medical Devices" and "Technical Considerations for Additive Manufactured Medical Devices."
    • Performance Bench Test: Conducted according to ISO 20795-1:2013, which specifies requirements for denture base polymers.

    The table 5.2 "Comparison of Performance Bench Test" shows the acceptance criteria (specifications of Type 4 resin) and the reported performance of the subject device (DENTCA Base Hi-Impact and Premium), the predicate device (Halley Resin), and a reference device (DENTCA Denture Base II). All listed devices "Meet the consensus STD" or are "Not Detectable" for Residual Methylmethacrylate, indicating they meet the specified physical properties.

    This document describes the testing for a physical material, not an AI/ML algorithm. Therefore, the requested details about multi-reader multi-case studies, ground truth establishment for AI, sample sizes for training sets, or expert qualifications are not applicable and not present in the provided text.

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