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K Number
K222424
Device Name
Protect-It Custom Fit Dental Guard
Manufacturer
DOC Brands, Inc.
Date Cleared
2022-10-07

(57 days)

Product Code
OBR
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K091660,K150492,K151149
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.

Device Description

Protect-It Custom Fit Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is made of a single thermoplastic resin, ethylene vinyl acetate copolymer, EVA, which is easily molded to the teeth when heated. It is a full-occlusal guard worn on the upper teeth, providing a cushion to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth associated with bruxism.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device: DOC Brands, Inc.'s Protect-It Custom Fit Dental Guard. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would typically be done for a new or high-risk device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a test set, expert adjudication, MRMC studies, standalone performance, or training set details for an AI/ML device.

The relevant sections of the document describe:

  • Substantial Equivalence Discussion: This is the core of the submission, comparing the subject device to a predicate (DenTek Oral Care, Inc.'s Ready-Fit Disposable Dental Guard - K151149) and a reference device (DenTek Oral Care, Inc.'s Custom Comfort Nightguard Version 2 - K091660) across various characteristics like manufacturer, 510(k) #, device classification, regulation #, product code, regulatory class, description, packaging, design, indications for use, OTC/Rx status, user population, technological characteristics, duration of use, materials, physical properties (tensile strength, elongation, hardness, melt index, density), fit, dimensions, weight, sterilization, and cleaning method.
  • Non-Clinical Performance Testing: This section details "bench testing" and "biocompatibility testing."
    • Bench Testing: An "in-home use test (IHUT)" was conducted to validate the design and performance expectations, specifically verifying reusability. The document references "Section 18: Bench Testing, Attachment 4A: Bench Test Protocol, 4B: Bench Test Engineering Study, and Attachment 4C: Bench Test Data" which are not provided in the given text.
    • Biocompatibility Testing: Four tests were performed according to ISO standards: In-vitro Cytotoxicity (ISO 10993-5:2009(E)), Skin Sensitization (ISO 10993-10:2021(E)), Intracutaneous Reactivity (ISO 10993-23:2021(E)), and Oral Mucosa Irritation (ISO 10993-23:2021(E)). The results indicated the device was non-cytotoxic, non-sensitizer, non-reactive, and non-irritant, respectively.

In summary, the provided document is a regulatory submission for substantial equivalence of a physical dental guard, not a study proving an AI/ML device meets acceptance criteria through a rigorous test set and expert review. Therefore, I cannot extract the specific information requested in your prompt.

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