Search Results

The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean between interdental space as it is done with floss, and other interdental cleaners such as tooth picks.

The Easy Brush with fluoride is an interdental brush designed to clean between teeth. It is composed of 4 parts (a handle, a wire, bristles, and a cap). The wire is twisted around the nylon filaments to create the brush, and then is molded onto a plastic handle. It is then coated with a solution containing flavor and sodium fluoride and then capped off.

This document describes DenTek Oral Care Inc.'s Easy Brush with fluoride. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (an interdental brush with fluoride) and focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It covers:

• Device Identification: Name, classification, predicate devices.
• Intended Use: Mechanically remove plaque and food particles, reduce tooth decay.
• Technological Characteristics: Components (handle, wire, bristles, cap), coating with flavor and sodium fluoride.
• Substantial Equivalence: Comparison to existing FDA-cleared devices (Oral-B Woodsticks with Fluoride and Johnson & Johnson Fluoride Dental Floss, Mint Waxed).
• Biocompatibility: Justified by reference to existing approved devices and safe levels of sodium fluoride in public water.
• FDA Clearance Letter: Formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide a table of acceptance criteria or details about a study to prove the device meets them because this information is not present in the provided text.

To answer your request, the input text would need to include sections detailing performance specifications, study design, results, and expert involvement.

Ask a specific question about this device