21 CFR 872.1 - Scope.
(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.
(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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
- 21 CFR 872.5580 — Oral Rinse to Reduce the Adhesion of Dental Plaque.
- 21 CFR 872.4770 — Temporary Mandibular Condyle Reconstruction Plate.
- 21 CFR 872.3640 — Endosseous Dental Implant.
- 21 CFR 872.3630 — Endosseous Dental Implant Abutment.
- 21 CFR 872.3930 — Bone Grafting Material.
- 21 CFR 872.3661 — Optical Impression Systems for CAD/CAM.
- 21 CFR 872.3070 — Dental Amalgam, Mercury, and Amalgam Alloy.