(80 days)
The FLUID CONTROL device is a dental operative unit accessory that allows for the controlled delivery of a particular rate of air and/or fluid from a pressurized source during various dental procedures.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "Fluid Control." This document primarily focuses on the FDA's decision of substantial equivalence for the device to legally marketed predicate devices, allowing it to be marketed.
Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies. These details are typically found in the device's 510(k) submission summary or a separate performance study report, not in the FDA's decision letter itself.
Therefore, I cannot provide the requested information based solely on the provided text. The document confirms the device's regulatory class, product code, and indications for use, but not the technical details of its performance validation.
§ 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.