21 C.F.R. § 872.1 Scope.
Title 21 - Food and Drugs
(a) This part sets forth the classification of dental devices intended for human use that are in commercial distribution. (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 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. (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. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/cdrh.guidance.php. [52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19737, Apr. 22, 2003]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart A—General Provisions
§ 872.1 Scope.