(91 days)
The intraoral camera system, Digital Doc, of Digital Doc, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Digital Doc." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter primarily focuses on:
- The FDA's review of the 510(k) submission.
- The determination of substantial equivalence.
- Regulatory classifications and requirements.
- Instructions for marketing the device.
- Contact information for further inquiries.
The "Indications for Use" section (page 2 of the uploaded document) describes the purpose of the device (to provide a view of the mouth for dentists to describe procedures and show before/after views to patients), but it does not specify performance metrics or studies.
Therefore, I cannot provide the requested information, as none of it is present in the provided text.
§ 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.