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K Number
K243516
Device Name
Remi Custom Night Guard
Manufacturer
GrindGuard Inc
Date Cleared
2025-02-10

(89 days)

Product Code
MQC
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K200125,K241369
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Remi Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

Device Description

The Remi Custom Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a dental device called the "Remi Custom Night Guard." It states that the device is substantially equivalent to a legally marketed predicate device (LIJIA Night Guard), meaning a full clinical study with acceptance criteria and a detailed study report is not required.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document explicitly states:

  • "no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." (page 6)

Instead, the submission relies on:

  • Comparison to a Predicate Device: The Remi Custom Night Guard is shown to have the same indications for use, product code, classification, anatomical sites, sterility, patient removability, and general technological features as the predicate LIJIA Night Guard (K241369).
  • Non-Clinical Performance Testing:
    • Durability testing: Completed, but no details on specific acceptance criteria or results are provided.
    • Internal manufacturing validation: Performed to test the dimensional accuracy of the manufacturing process, but no specific acceptance criteria or results are provided.
    • Biocompatibility testing: Performed in accordance with ISO 10993, with cytotoxicity testing completed. No specific acceptance criteria or results are provided beyond the statement that it was completed.

In summary, because this is a 510(k) submission based on substantial equivalence to a predicate device and explicitly states that no clinical studies were deemed necessary, the detailed information about acceptance criteria and a study to prove device performance (as requested in the prompt) is not present in this document.

N/A