Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4120](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4120) → QRY — Dental Navigation System

# QRY · Dental Navigation System

_Dental · 21 CFR 872.4120 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/QRY

## Overview

- **Product Code:** QRY
- **Device Name:** Dental Navigation System
- **Regulation:** [21 CFR 872.4120](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4120)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## 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](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/QRY/K232148.md) | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Feb 21, 2024 | SESE |
| [K222750](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/QRY/K222750.md) | Yomi Robotic System | Neocis, Inc. | Dec 8, 2022 | SESE |
| [K222049](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/QRY/K222049.md) | Yomi Robotic System | Neocis, Inc. | Nov 4, 2022 | SESE |
| [K211701](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/QRY/K211701.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/QRY](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/QRY)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com