21 CFR 872.3240 — Bur, Dental
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3240
Identification
A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EJL | Bur, Dental | 1 | 27 | |
| NME | Bur, Diamond Coated, Reprocessed | 1 | 0 | 3rd Party |
