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510(k) Data Aggregation

    K Number
    K072147
    Device Name
    DEN TEK COMFORT FIT NIGHTGUARD
    Manufacturer
    DEN TEK ORAL CARE, INC.
    Date Cleared
    2007-08-30

    (27 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K063483,K022809
    Why did this record match?
    Device Name :

    DEN TEK COMFORT FIT NIGHTGUARD

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

    The DenTek Comfort Fit is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

    Device Description

    The Comfort Fit consists of two bite pads and one buccal retaining strap. The bite pads consist entirely of Elvax, and the buccal retaining strap consists of Elvaloy. The bite pads move along the buccal strap to adjust to the individual user needs with the strap always contained within the wings of the bite pads. There are 4 positions of adjustability for each molar pad. There is a built in wear indicator, which helps the user determine when they need to replace their Comfort Fit.

    AI/ML Overview

    This premarket notification (K072147) for DenTek's Comfort Fit NightGuard is a Special 510(k) notice. This means the submission focuses on modifications to an already cleared device and demonstrates substantial equivalence to predicate devices, rather than establishing a completely new device's safety and effectiveness through extensive clinical trials. Therefore, the document does not contain the detailed clinical study information typically found in a traditional 510(k) or a PMA where new acceptance criteria and their proof are established.

    Based on the provided text, the device's acceptance criteria are framed within the context of substantial equivalence to predicate devices rather than performance metrics from a specific study designed to meet predetermined acceptance thresholds.

    Here's an analysis based on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Inferred from Substantial Equivalence Basis)Reported Device Performance (Inferred from Description)
    Intended Use: Protection against bruxism or nighttime teeth grinding, reduction of damage to teeth, prevention of noise.Intended Use: Same as predicate devices. The Comfort Fit is "indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding."
    Technological Characteristics: Similar materials, design, and operating principles to predicate devices.Technological Characteristics: Consists of "two bite pads and one buccal retaining strap." Bite pads are "Elvax," and the strap is "Elvaloy." Features "4 positions of adjustability for each molar pad" and a "built-in wear indicator." These are presented as modifications consistent with the function of predicate devices.
    Material Safety & Biocompatibility: Materials used should be safe for oral contact (implied by use of Elvax and Elvaloy, likely established for predicate devices).Material Safety & Biocompatibility: Elvax and Elvaloy are specified. These materials are generally recognized as safe for medical devices and are likely similar or identical to materials used in the predicate devices.
    Performance (implicitly): Device should effectively protect against bruxism, reduce damage, and prevent noise without causing harm.Performance (implicitly): The "Comfort Fit is a modification to the DenTek NightGuard" (predicate K063483). The claim of substantial equivalence implies that the Comfort Fit performs comparably to the predicate devices in fulfilling its intended use. No specific quantitative performance metrics (e.g., reduction in grinding force, duration of wear) are provided.

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

    • None stated. This submission is a Special 510(k) for modifications and relies on demonstrating substantial equivalence to predicate devices. It does not present a new clinical study with a "test set" in the traditional sense. The comparison is primarily based on intended use, technological characteristics, and potentially material safety data if new materials were introduced (which doesn't appear to be the case for the type of material, just potentially a formulation or processing).

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    • Not applicable. No external "ground truth" establishment from experts is mentioned in this type of submission. The FDA reviews the provided information and determines substantial equivalence based on regulatory guidelines.

    4. Adjudication Method for the Test Set

    • Not applicable. No test set or independent adjudication is described.

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

    • Not performed/reported. This is not a study design relevant to a mechanical device like a nightguard in a Special 510(k) submission. MRMC studies are typically for diagnostic imaging devices where human readers interpret images with and without AI assistance.

    6. Standalone (Algorithm Only) Performance Study

    • Not performed/reported. This device is a physical product, not an algorithm, so a standalone algorithm performance study is not applicable.

    7. Type of Ground Truth Used

    • Not applicable for a new ground truth. The "ground truth" here is essentially the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance and market history. The Comfort Fit aims to show it is as safe and effective as these predicates.

    8. Sample Size for the Training Set

    • Not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device submission. The device is a physical nightguard.

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

    • Not applicable. As above, no training set or associated ground truth establishment process is relevant to this submission.

    In summary:

    This Special 510(k) provides information to demonstrate that DenTek's Comfort Fit NightGuard is substantially equivalent to legally marketed predicate devices. The "proof" that the device meets "acceptance criteria" is the argument of this substantial equivalence based on its intended use, similar indications, principles of operation, and technological characteristics (including materials and adjustment features). It is not based on a new clinical study with performance metrics against predefined acceptance criteria.

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