(96 days)
The A-dec Self-Contained Water System is intended for use in providing water to the dental syringe, various handpiece devices, and cuspidor cup-fill. The system allows for flushing and waterline maintenance to help prevent contamination and maintain clean dental unit waterlines.
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This document is a 510(k) clearance letter from the FDA for a dental water system. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in a study as it pertains to medical device performance evaluation.
This type of information is usually found in the 510(k) summary or the actual submission documents, which are not provided here. The letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on 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.