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The Breathtique Tongue Scraper is intended to be used to remove bacterial plaque and food debris from the surface of the tongue.

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The provided document is a 510(k) premarket notification letter from the FDA for a device called "Breathtique Tongue Scrapers." This letter does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

The purpose of a 510(k) submission is to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its effectiveness or safety through new clinical studies. The FDA's letter states that they have reviewed the submission and determined the device is substantially equivalent to legally marketed devices, allowing it to be marketed subject to general controls.

Therefore, I cannot provide the requested information based on the given input. The document is essentially an approval letter to market the device, based on its equivalence to existing products, and does not detail performance testing or clinical studies.

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