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K Number
K082301
Device Name
GRIND NO MORE
Manufacturer
PLACONTROL INC.
Date Cleared
2008-10-06

(55 days)

Product Code
OBR
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K072147
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Grind No More 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.

Device Description

Grind No More is a posterior-only occlusive mouthguard, consisting of two molar bite plates connected by a buccal retention band.

AI/ML Overview

This document is a 510(k) summary for Placontrol, Inc.'s "Grind No More" mouthguard. It states that the device is substantially equivalent to a predicate device and provides its intended use. However, it does not describe any specific acceptance criteria or an analytical study that proves the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (DenTek Oral Care Inc.'s Comfort Fit NightGuard, K072147), rather than providing detailed performance data against specific acceptance criteria.

Therefore, the following requested information cannot be extracted from the provided text:

  1. A table of acceptance criteria and the reported device performance: Not provided. The submission argues substantial equivalence based on intended use, technological characteristics, and principles of operation, rather than specific performance metrics against pre-defined acceptance criteria.
  2. Sample sized used for the test set and the data provenance: No test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set is described.
  4. Adjudication method for the test set: Not applicable as no test set is described.
  5. 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 device is a mouthguard, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mouthguard, not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no specific test data or ground truth establishment is described. The basis for approval is substantial equivalence to a predicate device.
  8. The sample size for the training set: Not applicable as no training set is described.
  9. How the ground truth for the training set was established: Not applicable as no training set is described.

Summary from the document:

The document outlines the regulatory submission for a Class I unclassified medical device (mouthguard). The core of the submission is a claim of substantial equivalence to a predicate device (DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147)). The arguments for substantial equivalence are based on:

  • Same intended uses and similar indications: "Grind No More 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." which is similar to the predicate device.
  • Similar technological characteristics: Both devices are posterior-only occlusive mouthguards with two molar bite plates connected by a buccal retention band.
  • Similar principles of operation.

The FDA found the device substantially equivalent for the stated indications for use, without requiring specific performance testing against pre-defined acceptance criteria as would be expected for a device with novel technology or higher risk classification.

N/A