DENTAL ARCH BAR
Device Facts
| Record ID | K820944 |
|---|---|
| Device Name | DENTAL ARCH BAR |
| Applicant | Unisplint Corp. |
| Product Code | DYX · Dental |
| Decision Date | May 5, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.
