(63 days)
Allow introl of the manation and observator
S595 Intra Oral Camera
This document is a 510(k) summary for the Sopro 595 Intra Oral Camera. It states that the device is substantially equivalent to other marketed intra-oral cameras and does not provide specific acceptance criteria or a study proving the device meets them.
Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence based on design, technology, specifications, and intended use, rather than presenting a performance study with detailed acceptance criteria.
Specifically, the document states:
- "SOPRO feels the S595 Intra Oral Camera is substantially equivalent to the many marketed devices already in commercial distribution."
- "The design of the S595 is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same, SOPRO feels that these minor differences have no impact on the safe use and/or effectiveness of the device."
This indicates a comparison to predicate devices rather than a standalone performance study with defined acceptance criteria and statistical analysis.
§ 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.