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    K Number
    K972369
    Device Name
    SEALAPEX
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1997-08-15

    (51 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K961708,K841910,K944480
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K961708

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

    Kerr Modified Sealapex Root Canal Sealer is a two- paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is intended for use as a root canal sealer to be used in conjunction with gutta percha or silver endodontic points.

    Device Description

    Kerr Modified Sealapex Root Canal Sealer is a two- paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material.

    AI/ML Overview

    This document describes a 510(k) submission for a modified root canal sealer, not an AI/ML powered device. Therefore, a table of acceptance criteria and reported device performance and other AI/ML specific information cannot be extracted from the document. The document describes changes to a root canal sealer formulation and provides evidence of substantial equivalence to a predicate device.

    However, I can provide a summary of the provided information regarding the modified Sealapex Root Canal Sealer to address the intent of understanding the device's validation.

    Device: Kerr Modified Sealapex Root Canal Sealer

    Purpose of Submission: To gain market clearance for an updated formulation of Sealapex Root Canal Sealer with two modifications:

    1. Substitution of poly(methylene methyl salicylate) resin with Neopentyl glycol disalicylate/trimethylol propane trisalicylate (NPG-TMP salicylate) resin to remove formaldehyde from the manufacturing process.
    2. Addition of bismuth trioxide to increase radiopacity by fifty percent.

    Study Type: This is a 510(k) submission for a medical device (root canal sealer), demonstrating substantial equivalence, not a study of an AI/ML system. The "studies" mentioned are related to the chemical and biological properties of the material.

    Acceptance Criteria and Device Performance (Based on the provided text):

    Since this is not an AI/ML device, the typical acceptance criteria for AI/ML performance metrics (e.g., AUC, sensitivity, specificity) are not applicable. Instead, the "acceptance criteria" can be inferred from the regulatory requirements for substantial equivalence and the performance standards for dental root canal sealing materials.

    Acceptance Criterion (Inferred from regulatory context)Reported Device Performance (Summary from document)
    Material Safety/BiocompatibilityDemonstrated in extensive animal histopathology studies. NPG-TMP salicylate resin previously successfully and safely used in Kerr's Life Cavity Base/Liner (K961708), based on extensive animal histopathology studies showing biocompatibility and ability to stimulate hard tissue formation. Bismuth trioxide is a commonly used radiopaquing agent in other FDA-marketed root canal sealers (e.g., Procosol, Grossman's Sealer, Wach's Paste, Diaket, AH-26).
    Material Efficacy/PerformanceDemonstrated by comparison testing against predicate devices to the requirements of ISO International Standard 6876 for Dental root canal sealing materials. (Specific results are not in this excerpt but are mentioned as being elsewhere in the submission).
    RadiopacityIncreased by fifty percent due to the addition of bismuth trioxide. (The document notes EH-26 has 60% by weight bismuth trioxide).
    Working TimeOriginal formulation had a previous 510(k) (K944480) for minor formulation changes to extend working time. The current submission's changes do not appear to alter this aspect, but rather focus on safety of synthesis and radiopacity.
    Substantial EquivalenceFDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (AUG 15 1997 letter).

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

    • Test Set Sample Size: Not specified in the provided text. The "test set" here refers to the materials and animals used in the histopathology studies and the samples used for ISO 6876 testing.
    • Data Provenance: The animal histopathology studies are internal ("Copies of reports of these studies are included elsewhere in this submission"). Comparison testing to ISO 6876 is also internal. Country of origin is thus likely the USA where Kerr is based, but not explicitly stated. These were prospective studies designed to evaluate the new formulation.

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

    • Number of Experts: Not explicitly stated. For animal histopathology, typically veterinary pathologists would interpret the tissue samples. For ISO standard testing, laboratory personnel and potentially experts in dental material science would perform and interpret the tests.
    • Qualifications: Not specified, but implied to be appropriately qualified professionals for histopathology and dental material testing.

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

    • Not applicable/Not specified for this type of device submission. Adjudication methods are typically used in clinical trials for endpoint determination or in image interpretation studies.

    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:

    • Not applicable. This is not an AI/ML device, so no MRMC study or AI assistance is relevant.

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

    • Not applicable. This is not an AI/ML device.

    6. The type of ground truth used:

    • For Safety: Histopathology (evidence of biocompatibility, tissue response, hard tissue formation).
    • For Efficacy/Performance: Results from objective laboratory tests conforming to ISO International Standard 6876 for Dental root canal sealing materials (e.g., flow, film thickness, working time, setting time, solubility, dimensional stability, radiopacity).
    • For Substantial Equivalence: Comparison of material properties and biological performance to legally marketed predicate devices that meet FDA requirements.

    7. The sample size for the training set:

    • Not applicable for this type of device. The term "training set" is used for AI/ML models. For this device, the "training" can be considered the cumulative knowledge and testing from prior formulations and predicate devices, as well as the newly conducted studies.

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

    • Not applicable for this type of device.
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