(213 days)
The Foshion Chair Mounted Dental Unit is intended to supply power and serve as a base for dental devices and accessories. The product includes a dental chair, operating light, x-ray viewer, control panel, low and high speed turbine hand pieces, 3-way syringe and air foot control. The unit is intended for use in the dental office or clinic and is used by trained dentists and/or dental technicians and assistants.
The Foshion Chair Mounted Dental Unit is a dental operative unit attached to a dental chair. There are three main parts to the product: a dental chair, a dental unit, and a stool for the dentist. The dental chair has adjustable headrest, backrest, seat with extension for leg support, and armrests. The dental unit consists of a floor box to which are attached a number of operative units: light, x-ray viewer, cuspidor, cup filling device, control panel, instrument tray, and foot control. The instrument panel also includes a 3-way syringe, saliva ejector, air suction, and handpiece attachments
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria.
The document is a 510(k) summary for a dental unit, and it focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria.
The key points from the provided text are:
- Device Name: Foshion Chair Mounted Dental Unit
- Intended Use: To supply power and serve as a base for dental devices and accessories in a dental office or clinic.
- Technological Characteristics: Similar to the predicate device.
- Conclusion: "There are no significant differences between the Foshion Chair Mounted Dental Unit and the predicate device; therefore, the proposed device does not raise any questions regarding safety and effectiveness." and "The Foshion Chair Mounted Dental Unit, as designed, is as safe and effective as the predicate device. Comparisons have been made to a legally marketed predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market."
This type of submission (510(k)) often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new performance studies against specific, quantitative acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, MRMC study, etc.) is not present in this document.
§ 872.6250 Dental chair and accessories.
(a)
Identification. A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.(b)
Classification. Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.