NME · Bur, Diamond Coated, Reprocessed
Dental · 21 CFR 872.3240 · Class 1
Overview
| Product Code | NME |
|---|---|
| Device Name | Bur, Diamond Coated, Reprocessed |
| Regulation | 21 CFR 872.3240 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
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.
Cleared Devices (0)
No cleared devices on record.
