(61 days)
The PerioView Model DV-1 Fiberscope and Window Sheath is intended to be used with the PerioView family of dental instruments in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath the intact gum line within the oral cavity.
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I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter for a medical device (PerioView Model DV-1 Fiberscope and Window Sheath), but it does not contain any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter primarily focuses on:
- Confirming the substantial equivalence of the device to legally marketed predicates.
- Outlining regulatory responsibilities and contacts.
- Stating the intended indications for use.
Therefore, I cannot extract the specific technical details about device performance tests and validation studies 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.