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) → MXF — System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation

# MXF · System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation

_Dental · 21 CFR 872.4120 · Class 2_

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

## Overview

- **Product Code:** MXF
- **Device Name:** System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
- **Regulation:** [21 CFR 872.4120](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4120)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K022803](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MXF/K022803.md) | WATERLASE FOR APICOECTOMY | Biolase Technology, Inc. | Feb 3, 2003 | SESE |
| [K013908](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MXF/K013908.md) | WATERLASE MILLENNIUM | Biolase Technology, Inc. | Feb 12, 2002 | SESE |
| [K012511](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MXF/K012511.md) | WATERLASE MILLENNIUM | Biolase Technology, Inc. | Jan 18, 2002 | SESE |
| [K990908](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MXF/K990908.md) | MILLENNIUM | Endo Technic Corp. | May 27, 1999 | SESE |
| [K990219](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MXF/K990219.md) | MODIFICATION OF MILLENNIUM | Biolase Technology, Inc. | Feb 24, 1999 | SESE |

## Top Applicants

- Biolase Technology, Inc. — 4 clearances
- Endo Technic Corp. — 1 clearance

---

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

**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