(80 days)
The Princess Syringe is an air and water spray syringe assembled as a dental handpiece. It is intended to deliver air and water spray during dental procedures.
The Princess Syringe is an air and water spray syringe assembled as a dental handpiece. This device has only one as of the orgal causiv during dental procedures.
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "Princess Syringe". This document primarily discusses the regulatory approval of the device and its substantial equivalence to previously marketed devices.
It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.