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SEE ATTACHED DEVICE SAMPLE (WHEN AVAILABLE, BRISTLE SAMPLE WILL BE SUBMITTED UPON REQUEST. BLACK DOTS INDICATE LOCATION OF THE TOOTH BRUSH BRISTLES). OUR PERFORMANCE AND REFERENCE CLAIMS TO THE USE OF THE PLAQ-ATAQ-I ARE: - 1) USED AS A REGULAR TRADITIONAL AND CURRENTLY MARKETED TOOTH BRUSH (SEE ORAL B - CREST-COMPLETE - REACH - COLGATE PLUS - TOP CARE - ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ) - 2) OVER THE COUNTER DENTIFRICE. - 3) THE LIQUID SPRAY SYSTEM INCORPORATED IN THE TOOTH BRUSH BODY CAN BE EMPLOYED FOR THE VALUES THAT THE MULTI-JETS PROVIDE. - 4) THE PLAIN TAP WATER STREAM IS FINGER-TIP CONTROLLED BY AN EASY, HAND-HELD TURNING VALVE (SEE TELEDYNE WATER PIK(R) AND HYDRO-FLOU™ MODELS). - 5) THE LIQUID STREAM FLUSHES OUT LOOSE PLAQUE AND DEBRIS BETWEEN THE TEETH AND GUMS THAT THE TOOTH BRUSH CANNOT REACH.

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I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for the device mentioned in the provided text. The documents do not contain the necessary information to address your specific points about device performance, study details, ground truth establishment, or expert involvement.

The provided text is a "Substantial Equivalence" letter from the FDA for a device named "PLAQ-ATAQ™-1," which appears to be a toothbrush with a liquid spray system. This letter primarily focuses on the regulatory clearance of the device based on its substantial equivalence to previously marketed predicate devices. It does not include performance acceptance criteria or detailed study information.

The sections you've highlighted for inclusion in your request (1-9) are typically found in a clinical study report or a 510(k) summary that addresses performance testing, which is separate from the formal FDA clearance letter.

Therefore, I cannot extract the requested information from the provided text.

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