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510(k) Data Aggregation

    K Number
    K111836
    Device Name
    PERMASHADE VENEER CEMENT
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    2011-09-16

    (79 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K974413,K931309
    Why did this record match?
    Reference Devices :

    K974413, K931309

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

    PermaShade Veneer Cement can be used for permanent cementation of porcelain, zirconia, composite and other indirect veneers.

    Device Description

    PermaShade Veneer Cement is a light-cured, moderately viscous, permanent resin cement. It is 66.5% filled by mass, is available in four shades, and has very low shrinkage and color change properties.

    AI/ML Overview

    The provided submission describes a dental cement, not an AI/ML powered medical device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML is not applicable. The document discusses a Traditional 510(k) for a dental cement (PermaShade Veneer Cement) and compares its characteristics and performance to legally marketed predicate devices, PermaFlo and Variolink Veneer, to establish substantial equivalence.

    However, I can extract the information provided regarding the device's characteristics and performance testing in a general sense, aligning with the spirit of the request as much as possible for a non-AI/ML device.

    Acceptance Criteria and Device Performance for PermaShade™ Veneer Cement

    CharacteristicAcceptance Criteria (Predicate Reference)Reported Device Performance (PermaShade Veneer Cement)
    Intended UsePermanent cementation of ceramic and composite restorations (from Variolink Veneer's intended use listed).Permanent cementation of indirect porcelain, zirconia, and composite veneers.
    Intended UserDental professional (same as predicates).Dental professional.
    CompositionDimethacrylate-based, filled resin (same as predicates).Dimethacrylate-based, filled resin.
    Type of CurePhotochemical (same as predicates).Photochemical.
    Percent Fill (m/m)68% (for PermaFlo) and 47-66% (for Variolink Veneer).66%.
    Filler Particle SizeAverage 700 nm (for PermaFlo) and 40-300 nm (for Variolink Veneer).13 - 700 nm.
    Delivery SystemSyringe (same as predicates).Syringe.
    Multiple ShadesYes (same as predicates).Yes (available in four shades).
    Physical PropertiesTested and characterized according to ISO 4049 (Same as predicates).Tested against predicates as outlined in ISO 4049; demonstrated equivalent in vitro performance.
    BiocompatibilityTested per ISO 10993-1 and ISO 7405 (Same as predicates).Tested per ISO 10993-1 and ISO 7405; product is safe when used as instructed.

    Study Information (Based on the provided text, adapted for a non-AI/ML device):

    The submission indicates that PermaShade Veneer Cement was tested to demonstrate substantial equivalence to the predicate devices, PermaFlo and Variolink Veneer.

    1. Sample Size used for the test set and data provenance:

      • The document states that the device was "tested against the predicates listed above as outlined in ISO 4049" and demonstrated "equivalent in vitro performance."
      • Specific sample sizes for these tests are not provided in the excerpt.
      • The data provenance is in vitro testing, likely conducted internally by Ultradent Products, Inc. No country of origin of the data is specified beyond the company's location in South Jordan, Utah, USA. The testing methodology followed an international standard (ISO 4049).

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • This question is not applicable as the evaluation of a dental cement's physical and biocompatibility properties typically relies on standardized laboratory tests and measurements rather than expert human interpretation of images or clinical data for ground truth.

    3. Adjudication method for the test set:

      • This is not applicable as there is no mention of human-reviewed test sets or adjudication for this device's evaluation.

    4. 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:

      • This is not applicable as the device is a dental cement, not an AI/ML system, and therefore, no MRMC studies or AI assistance are mentioned.

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

      • This is not applicable as the device is a dental cement, not an algorithm.

    6. The type of ground truth used:

      • For physical properties, the "ground truth" would be established by standardized laboratory measurements (e.g., strength, shrinkage, color change) according to ISO 4049, with comparison to the performance of predicate devices.
      • For biocompatibility, the "ground truth" is established by standardized biological evaluation methods described in ISO 10993-1 and ISO 7405.

    7. The sample size for the training set:

      • This question is not applicable as the device is a dental cement and does not utilize a training set in the context of AI/ML.

    8. How the ground truth for the training set was established:

      • This question is not applicable as the device is a dental cement and does not utilize a training set in the context of AI/ML.
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