(71 days)
The A-dec 334/335 Delivery System Dental Unit and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
The A-dec 334/335 Delivery System Dental Unit and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
This document is a 510(k) premarket notification letter from the FDA regarding the A-dec 334/335 Delivery System. It states that the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, there is no information regarding acceptance criteria studies, device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
The document primarily focuses on the FDA's determination of substantial equivalence for a dental operative unit and accessories, confirming its classification and outlining regulatory compliance requirements. It does not contain the level of detail required to answer the specific questions about device performance and study methodology.
§ 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.