(301 days)
THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.
THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.
The provided document is a 510(k) premarket notification letter from the FDA for a dental operative unit. This type of document is a regulatory approval letter and does not contain acceptance criteria or study details regarding the performance of an AI/ML powered medical device.
The device described, "Compact Plus, Perfect Plus, Extreme Operative Dental Unit," is a dental chair and an attached operative dental unit intended to properly position a patient for routine dental procedures and serve as a base for other dental devices. It explicitly states, "THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT."
Therefore, it is a physical medical device, not an AI/ML powered device, and the information requested pertaining to AI/ML model performance, ground truth, expert adjudication, or comparative effectiveness studies is not applicable and cannot be extracted from this document.
§ 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.