(36 days)
The PerioView system by DentalView is a system intended for use in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath an intact gumline within the oral cavity.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called the "Dentalview Perioview System." It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information. The letter primarily focuses on regulatory approval based on substantial equivalence, not on the detailed technical data typically found in a study summary or clinical trial report.
§ 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.