(e) Guidance documents referenced in this part are available on the Internet at. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
(c) To avoid duplicative listings, a dental device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation.
(a) This part sets forth the classification of dental devices intended for human use that are in commercial distribution.