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510(k) Data Aggregation

    K Number
    K974483
    Device Name
    NTL-FLOW
    Manufacturer
    BISCO, INC.
    Date Cleared
    1998-02-09

    (75 days)

    Product Code
    EBF,33F
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K945604
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NTL-FLOW is indicated for: anterior esthetic restorative material for Class III, IV, and V as well as conservative Class I restorations not involving opposing occlusal wear for direct or indirect use. Direct Esthetic veneer restorative for masking stains and developmental anomalies. Pit and fissure sealant. core build-up material to replace missing tooth structure. Dental cement/luting agent and dental liner. Composite/porcelain repair material.

    Device Description

    NTL-FLOW is a dual-cure (light or heat and light) moderately filled (60%), radiopaque low modulus flowable composite. Its physical properties are similar to the predicate device and uses are identical. Like the predicate device, NTL-FLOW is a glass frit filled dimethacrylate composite. It hardens by a light or heat and light cure polymerization mechanism employing a light initiator, and a tertiary amine activator and peroxide initiator. Both devices are designed to be used with high quality dentin / enamel adhesive systems. The material can be used in a conventional fashion or it can be processed in a dedicated curing device that employs light, and a substantially oxygen free atmosphere created by flushing the device with an inert gas such as nitrogen. The heat is supplied by the lamp providing the light. The comparative low modulus facilitates the use of the material as a first increment liner that is intended to bond to the dental adhesive as well as the next increment composite.

    AI/ML Overview

    The provided 510(k) submission for NTL-FLOW is for a dental restorative material, not an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size and ground truth establishment) are not applicable.

    However, I can still extract information about the acceptance criteria and the study that demonstrates the device meets these criteria based on the provided text, focusing on the material's physical properties.

    Acceptance Criteria and Reported Device Performance

    The submission references non-clinical tests similar to those specified in ISO 4049 and American Dental Association Specification #27 for dental resin-based filling materials. These specifications typically define minimum acceptable standards for various physical properties.

    Acceptance Criteria (from referenced standards or implied by comparison)NTL-FLOW Reported PerformancePredicate Device (AELITEFLO) Reported Performance
    Diametral Tensile Strength (DTS)41.3 MPa39.0 MPa
    Flexural Modulus (Strength in three-point loading)(Implied to be acceptable)(Implied to be acceptable)
    CytotoxicityNon-toxic(Not explicitly stated for predicate, but implied safe for medical device use)
    Flow characteristics / SyringabilitySuperior to more highly filled materialsSuperior to more highly filled materials (similar to NTL-FLOW)
    FlexibilityHigh (achieved by imaginative balance of polymerizable resins)More flexible than conventional dental composites (similar to NTL-FLOW)
    RadiopacityRadiopaqueRadiopaque
    Barcol HardnessApproximately 10% lower than conventional composites(Not explicitly stated, but implied similar to predicate by overall similarity claim)
    Curing MechanismDual-cure (light or heat and light)Light-cure exclusively
    Filler ContentModerately filled (60%)Moderately filled (59% w/w)

    Study Information (Non-AI/ML focused):

    1. Sample size used for the test set and the data provenance: Not specified in the provided text for individual tests. The non-clinical tests were performed by the applicant (BISCO, Inc.) and a commercial testing laboratory (NAMSA for cytotoxicity). The data provenance is from laboratory testing of the material samples.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material property testing does not involve expert consensus for ground truth but rather standardized physical measurements.

    3. Adjudication method for the test set: Not applicable. Standardized laboratory tests have objective measurements that do not require adjudication.

    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.

    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 physical properties like Diametral Tensile Strength and Flexural Modulus, the "ground truth" is the empirically measured value obtained through standardized testing methods (e.g., ISO 4049, ADA Specification #27). For cytotoxicity, the ground truth is the result from a recognized biological evaluation test (conducted by NAMSA).

    7. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."

    8. How the ground truth for the training set was established: Not applicable.

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