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510(k) Data Aggregation

    K Number
    K132984
    Device Name
    SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2014-01-14

    (112 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K844349,K120736
    Why did this record match?
    Device Name :

    SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S

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

    Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

    Device Description

    Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

    AI/ML Overview

    The provided 510(k) summary describes a device, SR Vivodent S, SR Orthotyp S, SR Ortholingual S, which are preformed denture teeth. This notification is for a dental device, not an AI/ML powered medical device. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size) are not applicable to this type of device submission.

    The submission focuses on demonstrating substantial equivalence to predicate devices (SR Vivodent PE, SR Orthotyp PE, and Phonares II) through material composition, performance data, and indications for use.

    Here's the information that can be extracted from the provided text according to your request:

    1. A table of acceptance criteria and the reported device performance

    TestAcceptance Criteria (Standard)Reported Device Performance
    Artificial denture teeth performanceMeets requirements defined in ISO 22112:2005 (Artificial denture teeth)The device has been tested and meets these requirements.
    Flexural StrengthMeets requirements defined in ISO 10477:2004 (Polymer based crown & bridge materials)The device has been tested and meets these requirements.
    Water SorptionMeets requirements defined in ISO 10477:2004 (Polymer based crown & bridge materials)The device has been tested and meets these requirements.
    SolubilityMeets requirements defined in ISO 10477:2004 (Polymer based crown & bridge materials)The device has been tested and meets these requirements.
    Ball Indentation TestMeets requirements defined in DIN EN ISO 2039-1The device has been tested and meets these requirements.
    BiocompatibilityMeets requirements defined in ISO 10993 (Biological evaluation of medical devices)Biocompatibility testing and evaluation was carried out according to ISO 10993. The device's composition (PMMA) is well known and accepted as biocompatible.

    2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not applicable for this type of device. The submission references compliance with international standards for material properties and performance rather than clinical test sets with specified sample sizes or data provenance. The testing would have been conducted in a laboratory setting.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable. Ground truth in the context of AI/ML or diagnostic devices is not relevant here. The "ground truth" for this device is its adherence to established material and performance standards.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not applicable. This is a physical dental device, not an AI-assisted diagnostic tool.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

    • Not applicable.

    7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

    • The "ground truth" for this device's performance is compliance with international standards (ISO 22112:2005, ISO 10477:2004, DIN EN ISO 2039-1, ISO 10993) for material properties and physical performance.

    8. The sample size for the training set

    • Not applicable. This device does not involve machine learning or a "training set."

    9. How the ground truth for the training set was established

    • Not applicable.
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