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510(k) Data Aggregation

    K Number
    K202974
    Device Name
    DenTek Fresh Protect Dental Guard
    Manufacturer
    Medtech Products, Inc.
    Date Cleared
    2020-12-22

    (83 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K091660,K083400,K151149
    Why did this record match?
    Device Name :

    DenTek Fresh Protect Dental Guard

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

    The DenTek™ Fresh Protect™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

    Device Description

    The DenTek™ Fresh Protect™ Dental Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of an ethylene/vinyl acetate copolymer and utilizes a ready-to-wear, one-size-fits-all design. The fully occlusive guard is worn on the lower teeth, maintaining separation between the upper and lower teeth, thereby preventing the noise and damage associated with teeth grinding.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA for a dental guard, not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present.

    The document discusses the substantial equivalence of the DenTek™ Fresh Protect™ Dental Guard to a predicate device based on non-clinical performance data and biocompatibility tests.

    Here is a summary of the non-clinical performance data presented for the DenTek™ Fresh Protect™ Dental Guard:

    Acceptance Criteria and Device Performance (Non-Clinical)

    Acceptance CriteriaReported Device Performance
    Separation Test: Ability to keep teeth separated when jaw is clenched.Demonstrated the finished guard's ability to keep teeth separated when the jaw is clenched.
    Fit Test: Ability to accommodate a range of arch widths without heating or adjustments.Demonstrated the finished guard's ability to accommodate a range of arch widths without heating or adjustments.
    Wear Test: Durability for the intended use duration of 1-3 days.Demonstrated the finished guard's durability for the intended use duration of 1-3 days.
    Biocompatibility - In Vitro Cytotoxicity Assay (ISO 10993-5): Not cytotoxic.Demonstrated as not cytotoxic.
    Biocompatibility - Guinea Pig Maximization Test (Sensitization) (ISO 10093-10): Not a contact skin sensitizer.Demonstrated as not a contact skin sensitizer.
    Biocompatibility - Oral Mucosa Irritation Test (ISO 10993-10): Not irritating to the buccal mucosa.Demonstrated as not irritating to the buccal mucosa.

    Regarding the other requested points (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set size, training set GT):

    • Sample sized used for the test set and the data provenance: Not explicitly stated as this is a non-clinical bench testing and biocompatibility assessment, not a clinical study with a patient test set. The tests involved "finished guards" or specific materials.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for bench tests would be the measured physical properties or biochemical reactions. For biocompatibility, established ISO standards define the endpoints.
    • Adjudication method for the test set: Not applicable for non-clinical bench testing.
    • 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 document is not about an AI/ML device.
    • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/ML device.
    • The type of ground truth used: For the non-clinical tests, the ground truth is derived from the established physical and chemical measurements as per the referenced ISO standards and simulation studies.
    • The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
    • How the ground truth for the training set was established: Not applicable.

    In conclusion, the provided document is a 510(k) premarket notification for a physical medical device (dental guard) and thus does not contain the information relevant to an AI/ML device's acceptance criteria, study design, or ground truth establishment.

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