(85 days)
DENTAL UNIT AND ACCESSORIES ARE INTENDED FOR THE DENTISTS, AND DENTAL ASSISTANTS FOR TRADITIONAL AND NORMAL PATIENT PROCEDURES IN THE DENTAL OPERATORY. THE DESIGN FUNCTION, AND POSITIONING OF THE UNIT AND ACCESSORIES ARE SIMILAR TO MOST ALL OTHER DENTAL UNITS MANUFACTURED FOR THIS SPECIFIC PURPOSE OVER THE PAST TWENTY YEARS.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The provided document is a 510(k) clearance letter from the FDA for a dental unit and accessories, stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, product codes, and general information about marketing the device, but it does not delve into the specific details of performance studies or acceptance criteria.
§ 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.