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510(k) Data Aggregation

    K Number
    K143292
    Device Name
    TheraCal DC
    Manufacturer
    Bisco Inc
    Date Cleared
    2015-08-04

    (260 days)

    Product Code
    EJK,CLA
    Regulation Number
    872.3250
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K140132,K123265,K142178,K063237
    Why did this record match?
    Reference Devices :

    K140132, K123265, K142178

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

    TheraCal DC is indicated for use for:

      1. Pulpotomy
      1. Temporary filling material
      1. Repair of root perforations
    • Repair of furcation perforations 4.
      1. Repair of perforating internal and external resorptions
      1. Root-end filling in endodontic surgery
      1. Pulp exposures (direct pulp capping)
      1. Protective liner (Indirect Pulp Capping) and Base for use under a variety of substrates
    Device Description

    TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the TheraCal DC device, extracted from the provided text:

    Important Note: The provided document is a 510(k) summary for a dental material (TheraCal DC), not a software or AI-driven medical device. Therefore, many of the requested categories like "test set size," "ground truth experts," "adjudication method," "MRMC study," and "standalone performance" are not applicable in the context of this device and its regulatory submission. The information below reflects what is available in the document for a physical material.

    1. Table of Acceptance Criteria and Reported Device Performance

    Physical/Mechanical PropertyAcceptance Criteria (Implied / Comparator)Reported Device Performance for TheraCal DC
    Flexural StrengthComparable to or greater than predicate devicesGreater than the predicate devices
    Dimetral Tensile StrengthComparable to or greater than predicate devicesGreater than the predicate devices
    Working TimeMet design control inputsMet the design control inputs
    Bond Strength (Shear)Comparable to or greater than predicate devicesGreater than the predicate devices
    Radiopacity (ISO 4049:2009 7.14)Meets ISO requirements (1 mm > 1mm of alumina)Meets the ISO requirements
    Water Sorption (ISO 4049:2009)Meets ISO 4049 requirementsMeets the ISO 4049 requirements
    Water Solubility (ISO 6876:2012)Meets ISO 6876 requirementsMeets the ISO 6876 requirements
    Calcium ReleaseEquivalent to predicate devicesEquivalent to the predicate devices
    pH TestingEquivalent to predicate devicesEquivalent to the predicate devices
    Biocompatibility (ISO 7405:2008 & ISO 10993-1:2009)Meets requirements of testingMet the requirements of the testing

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: Not specified. This document summarizes and compares physical/mechanical properties and biocompatibility, which typically involve laboratory tests on material samples rather than a "test set" in the sense of patient data.
    • Data Provenance: Not specified. The tests are "in-house test method" or reference ISO/ANSI/ADA standards, suggesting laboratory testing. No information on country of origin or retrospective/prospective nature is relevant for this type of device.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Number of Experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing methods, not expert consensus on interpretations.
    • Qualifications of Experts: Not applicable.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable. Material property testing does not typically involve adjudication.

    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

    • MRMC Study: No, this is not an AI-driven device.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • Standalone Study: No, this is not an AI-driven device.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: The "ground truth" for the performance data mentioned is established through standardized laboratory test methods (e.g., ISO, ANSI/ADA standards) and direct comparison to legally marketed predicate devices. For biocompatibility, it's defined by compliance with ISO standards (ISO 7405:2008 and ISO 10993-1:2009).

    8. The Sample Size for the Training Set

    • Sample Size for Training Set: Not applicable. There is no "training set" in the context of a physical dental material. The material is developed and formulated based on scientific principles and then tested against established standards and predicate devices.

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

    • How Ground Truth for Training Set Was Established: Not applicable.
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