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) → KMW — Handpiece, Rotary Bone Cutting

# KMW · Handpiece, Rotary Bone Cutting

_Dental · 21 CFR 872.4120 · Class 2_

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

## Overview

- **Product Code:** KMW
- **Device Name:** Handpiece, Rotary Bone Cutting
- **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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K211584](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/KMW/K211584.md) | Oral Surgery Contra | Nakanishi, Inc. | Aug 19, 2021 | SESE |
| [K171155](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/KMW/K171155.md) | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | Nov 21, 2017 | SESE |
| [K162544](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/KMW/K162544.md) | OsteoMed PINNACLE Driver | Osteomed | Apr 4, 2017 | SESE |
| [K080939](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/KMW/K080939.md) | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | Jul 29, 2008 | SESE |
| [K994298](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/KMW/K994298.md) | FRIOS MICROSAW | Friadent GmbH | Feb 18, 2000 | SESE |
| [K971692](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/KMW/K971692.md) | OSTEOPOWER SYSTEM AND ACCESSORIES | Osteomed Corp. | Jun 27, 1997 | SESE |
| [K970953](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/KMW/K970953.md) | E-TYPE SPEED REDUCER CONTRA ANGLE | Nsk Nakanishi, Inc. | Apr 15, 1997 | SESE |
| [K932255](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/KMW/K932255.md) | YOUNG D'GRANULATOR | Young Dental Manufacturing Co. 1, LLC | Apr 15, 1994 | SESE |
| [K862110](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/KMW/K862110.md) | OSSEODENT DRILLING SYSTEM | Otc/America | Aug 7, 1986 | SESE |

## Top Applicants

- Nakanishi, Inc. — 2 clearances
- Friadent GmbH — 1 clearance
- Nsk Nakanishi, Inc. — 1 clearance
- Osteomed — 1 clearance
- Osteomed Corp. — 1 clearance

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

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