21 CFR 872.4600 — Lock, Wire, And Ligature, Intraoral
Dental (DE) · Subpart E—Surgical Devices · § 872.4600
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DYX | Lock, Wire, And Ligature, Intraoral | 2 | 11 | Implant |
