STERILIZED DENTAL BIT PACKAGING
Device Facts
| Record ID | K873698 |
|---|---|
| Device Name | STERILIZED DENTAL BIT PACKAGING |
| Applicant | Florida Diamond Instruments Corp. |
| Product Code | EJL · Dental |
| Decision Date | Dec 3, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3240 |
| Device Class | Class 1 |
Regulatory Classification
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.