(35 days)
The General Purpose Dental Tray is a single patient, single use, disposable device which is intended to conveniently provide general use auxiliary components for the administration of dental procedures.
The General Purpose Dental Tray is intended to conveniently provide the auxiliary components utilized during general dental procedures. The components are items that are commonly used during a variety of dental procedures. The general Purpose Dental Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
This document is a 510(k) summary for a General Purpose Dental Tray. It describes the device, its intended use, and its technological characteristics in comparison to a predicate device.
The provided text does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided. The document focuses on regulatory submission information rather than performance evaluation.
§ 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.