(666 days)
Infinity / Infinity Cross Flex Dental Systems are intended for use in general dental applications by providing the dental practitioner a user interface to control of the dental chair and attached dental devices. The, system delivers air, water and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Infinity / Infinity Cross Flex Dental Systems" does not contain any information regarding acceptance criteria, device performance metrics, study design (sample sizes, data provenance, expert qualifications, adjudication methods), or details about a multi-reader multi-case (MRMC) study or standalone algorithm performance.
This document is a standard FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies the product name, regulation number, regulatory class, and product code. It also outlines the general controls provisions of the Act that the manufacturer must comply with, and provides contact information for regulatory inquiries. The "Indications for Use" section simply states the intended general dental applications of the device, which involves controlling dental chairs and delivering air, water, and vacuum for patient treatment procedures.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the more detailed technical documentation submitted as part of the 510(k) application, which is not included here.
§ 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.