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    K Number
    K990155
    Device Name
    HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010
    Manufacturer
    KAY SEE DENTAL MFG. CO.
    Date Cleared
    1999-02-25

    (37 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K884081
    Why did this record match?
    Device Name :

    HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010

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

    Hydro-Cast Versa-Temp Eugenol-Free Provisional Cement is used for temporarily cementing crowns and bridges. Hydro-Cast Versa-Temp provides for easy seating of the temporary, very fast first stage cure with an excellent consistency that allows the removal of excess material from the work area and undercuts, and a rigid set combined with easy removal of the temporary.

    Device Description

    The device is a syringe dispensing system that dispenses a eugenol free temporary dental cement

    AI/ML Overview

    Acceptance Criteria and Study for Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement

    This document describes the acceptance criteria and the non-clinical performance testing conducted to demonstrate the substantial equivalence of the Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement.

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Initial Set: 90 sec +/- 30 sec (60-120 seconds)Min: 80 sec, Max: 91 sec
    Final Set: 3 min +/- 30 sec (150-210 seconds)Min: 175 sec, Max: 196 sec

    2. Sample Size and Data Provenance for Test Set

    • Sample Size: 10 random subgroups of three samples each, totaling 30 samples.
    • Data Provenance: The data was generated through internal non-clinical performance testing conducted by Kay-See Dental. The location of the testing is not explicitly stated beyond "Kay-See Dental performed test." It's a retrospective study of the device's characteristics.

    3. Number of Experts and Qualifications for Ground Truth

    Not applicable. This study focuses on the physical properties of a dental cement, specifically its setting times. The ground truth for setting times is established by predefined physical characteristics (rubbery consistency for initial set, hardened material for final set) observed during the testing, not by expert consensus or interpretation of images.

    4. Adjudication Method for Test Set

    Not applicable. As described above, the ground truth for setting times is determined by direct observation of physical changes in the material, not through expert adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    Not applicable. This is a non-clinical performance test for a dental cement, not a study involving human readers or AI assistance.

    6. Standalone (Algorithm Only) Performance

    Not applicable. This is a non-clinical performance test for a dental cement, not an algorithm-based device.

    7. Type of Ground Truth Used

    The ground truth used was based on objective physical observations during the testing process:

    • Initial Set: Defined as reaching a "rubbery consistency."
    • Final Set: Defined as becoming "hardened material."

    8. Sample Size for the Training Set

    Not applicable. This document describes a non-clinical performance test to confirm specifications of a physical product. There is no mention of a "training set" in the context of this type of testing.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. As there is no training set for this type of non-clinical testing, the establishment of its ground truth is irrelevant.

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