(334 days)
The AMC-20 is a self-contained mobile dental cart that is used for general dentistry and endodontic applications.
AMC-20 Mobile Dental Cart
This document is a 510(k) premarket notification from the FDA regarding the "AMC-20 Mobile Dental Cart." It is a regulatory approval letter and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the device was approved based on its substantial equivalence to existing devices, not on a new study demonstrating its performance against specific acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 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.