(70 days)
The A-dec Self-Contained Water System with Antimicrobial AlphaSan" is intended for use in general dental applications by providing water to the dental syringe, various handpiece ancillary devices, and cuspidor cup-fill. When used according to manufacturer's instructions, and in conjunction with the cleaner tablet ICX", the Antimicrobial AlphaSan" contained in the bottle helps to reduce microbial contamination.
A-dec Self-Contained Water System
The provided text from the FDA 510(k) summary for the A-DEC Self-Contained Water System does not contain any information about acceptance criteria or a study proving the device meets said criteria.
The document is a clearance letter from the FDA, stating that the device is substantially equivalent to a legally marketed predicate device. It defines the indications for use of the A-DEC Self-Contained Water System but does not include any performance data, clinical study results, or the methodology for any such studies.
Therefore, I cannot provide the requested information based on the given input.
§ 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.