(90 days)
The intraoral camera system, Opti, of CamSight Co., Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.
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The provided text is a 510(k) premarket notification letter from the FDA to CamSight Company, Incorporated, regarding their device "Opti," an intraoral camera system.
Based on the content of this document, none of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment can be provided.
This letter is an approval letter stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not contain any details about performance criteria, specific clinical studies, or technical evaluations that would typically be found in a study report or a more detailed submission.
Therefore, I cannot populate the table or answer the specific questions because the document does not contain any of the requested information about device performance or the studies used to demonstrate it.
§ 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.