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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.

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