(89 days)
To Remove adherent plaque and debris from the teeth and oral mucosa, to Reduce tooth decay in patients who are Physically unable to perform brushing. To Prevent Aspiration, which may be associated with mechanical brushing only in these patients.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Agatha-A-H2010." It indicates that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot provide the requested information based on the provided text. The letter only confirms that the device can be marketed and specifies its intended use and regulatory class.
§ 872.6510 Oral irrigation unit.
(a)
Identification. An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.