21 CFR 872.4120 — Saw, Bone, Ac-Powered
Dental (DE) · Subpart E—Surgical Devices · § 872.4120
Identification
A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DZH | Saw, Bone, Ac-Powered | 2 | 4 | 3rd Party |
| DZI | Drill, Bone, Powered | 2 | 48 | 3rd Party |
| DZJ | Driver, Wire, And Bone Drill, Manual | 2 | 31 | 3rd Party |
| KMW | Handpiece, Rotary Bone Cutting | 2 | 9 | 3rd Party |
| MXF | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation | 2 | 5 | 3rd Party |
| PLV | Dental Stereotaxic Instrument | 2 | 23 | |
| QRY | Dental Navigation System | 2 | 4 | SaMD |
