(191 days)
FOR USE TO REDUCE BACTERIA AND VIRUSES PRESENT IN DENTAL UNIT WATER LINE WATER. THE DEVICE CAN BE USED ON THE GENERAL PATIENT POPULATION, WITH THE EXCEPTION OF PATIENTS WHO ARE PREGNANT OF WHO ARE SENSITIVE TO IODINE.
DENTAL UNIT WATER TREATMENT CARTRIDGE
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA to Dentalpure Corporation for a "Dental Unit Water Treatment Cartridge."
It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines the general controls provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device. The document also includes the indications for use of the device.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, 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.