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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.

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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.

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