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510(k) Data Aggregation

    K Number
    K992519
    Device Name
    NRC NON-RINSE CONDITIONER
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    1999-10-22

    (86 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Used to clean instrumented enamel prior to restoration of tooth structure with selected dental adhesive and preventive dental materials.

    Device Description

    NRC™ NON-RINSE CONDITIONER is a no-rinse etching/ conditioning solution for use on enamel with selected adhesive and preventive dental materials.

    NRC ™ NON-RINSE CONDITIONER partially dissolves the minerals within the enamel. This partial dissolution results in increased surface area due to micro-porosities created in the affected substrates. This allows for more intimate contact and penetration of the sealant material with the tooth, increasing the potential for adhesion of the sealant. To aid in the adhesive bonding agent is applied to the acid treated surfaces.

    AI/ML Overview
    1. Acceptance Criteria and Reported Device Performance:

    NRC™ NON-RINSE CONDITIONER is a dental device intended for use as a no-rinse etching/conditioning solution on enamel. The provided summary does not explicitly state quantitative acceptance criteria or results from a performance study in the format of a table with specific metrics. Instead, the justification for safety and effectiveness is based on:

    Acceptance Criterion (Implicit)Reported Device Performance
    Biocompatibility/Safety: Non-mutagenic.Evaluated by the Ames Mutagenicity Test and found to be non-mutagenic.
    Functional Equivalence: Ability to partially dissolve enamel minerals, increase surface area, and allow intimate contact/penetration of sealant material for increased adhesion potential, similar to legally marketed predicate devices."NRC™ NON-RINSE CONDITIONER partially dissolves the minerals within the enamel. This partial dissolution results in increased surface area due to micro-porosities created in the affected substrates. This allows for more intimate contact and penetration of the sealant material with the tooth, increasing the potential for adhesion of the sealant."
    Material Safety/Prior Use: Components have a history of safe use in legally marketed devices."All of the components found in NRC™ NON-RINSE CONDITIONER have been used in legally marketed devices."

    1. Sample Size for Test Set and Data Provenance:

      • The provided 510(k) summary does not specify a distinct "test set" or its sample size for evaluating the NRC™ NON-RINSE CONDITIONER's performance with respect to its functional claims (e.g., enamel etching effectiveness, bond strength). The Ames Mutagenicity Test would have a specific sample size for its evaluation, but this is not detailed.
      • Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned for any studies.

    2. Number of Experts and Qualifications for Ground Truth:

      • No information is provided regarding the number or qualifications of experts used to establish any ground truth for performance studies related to the device's functional claims on enamel. The Ames test is a standard biological assay, and while it requires trained personnel, they are typically toxicology experts rather than clinical experts.

    3. Adjudication Method for Test Set:

      • Not applicable, as no clinical or interpretative test set requiring expert adjudication is described.

    4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

      • No MRMC study was done or reported in the provided summary. The device is a dental material, not an imaging or diagnostic AI tool that would typically involve human readers.

    5. Standalone (Algorithm Only) Performance:

      • Not applicable. This device is a chemical dental conditioner, not an algorithm or software. Its performance is assessed through material properties and biological safety.

    6. Type of Ground Truth Used:

      • Biocompatibility: The ground truth for biocompatibility (specifically mutagenicity) was established through the results of the Ames Mutagenicity Test, a well-established in vitro assay.
      • Functional Claims: For the functional claims related to enamel etching and increased surface area, the summary describes the mechanism of action rather than providing specific ground truth data from defined studies. It implies an understanding of dental material science. The basis for these claims relies on the chemical properties of the conditioner and analogies to predicate devices. There's no mention of pathology, clinical outcomes data, or expert consensus specific to this device's performance.

    7. Sample Size for Training Set:

      • Not applicable. The NRC™ NON-RINSE CONDITIONER is a physical/chemical dental product, not an AI algorithm requiring a training set.

    8. How Ground Truth for Training Set Was Established:

      • Not applicable, as there is no training set for this type of device.
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