QRY · Dental Navigation System
Dental · 21 CFR 872.4120 · Class 2
Overview
| Product Code | QRY |
|---|---|
| Device Name | Dental Navigation System |
| Regulation | 21 CFR 872.4120 |
| Device Class | Class 2 |
| Review Panel | Dental |
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232148 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Feb 21, 2024 | SESE |
| K222750 | Yomi Robotic System | Neocis, Inc. | Dec 8, 2022 | SESE |
| K222049 | Yomi Robotic System | Neocis, Inc. | Nov 4, 2022 | SESE |
| K211701 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | Feb 1, 2022 | SESE |
Top Applicants
- X-Nav Technologies, LLC — 2 clearances
- Neocis, Inc. — 2 clearances
