(60 days)
Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retro: it existing dental waterlines.
Pall Medical's Dental Unit Waterline Filtration System with Inline Handpiece Housing and Filtration Membrane
This document is a 510(k) clearance letter from the FDA for a medical device called "Pall Dental Filtration System with Inline Handpiece Housing and Filter Membrane." This type of document is a regulatory approval, not a scientific study report.
Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, and training sets is not available in the provided text.
The document primarily states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain the detailed study data that would typically be found in a scientific publication or a premarket approval (PMA) application.
§ 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.