(149 days)
The intra-oral camera system, Veracam, of Lumalite, Inc. is used to provide a view of the mouth so that it assists the dellife in describitits dollar procedures which the dentist has performed on him.
Veracam; Intra-Oral Camera System and Accessories
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Veracam Intra-Oral Camera System and Accessories, stating that the device is substantially equivalent to a legally marketed predicate device.
It outlines general regulatory requirements, but it does not detail any performance studies, acceptance criteria, or specific metrics of the device's performance. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.
§ 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.