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) → DZH — Saw, Bone, Ac-Powered

# DZH · Saw, Bone, Ac-Powered

_Dental · 21 CFR 872.4120 · Class 2_

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

## Overview

- **Product Code:** DZH
- **Device Name:** Saw, Bone, Ac-Powered
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K031793](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZH/K031793.md) | DENTATUS OSCIOMAT | Dentatus USA , Ltd. | Nov 13, 2003 | SESE |
| [K935443](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZH/K935443.md) | ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS | Osada Electric Co., Ltd. | Sep 20, 1994 | SESE |
| [K760958](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZH/K760958.md) | SURGICAL OSCILLATING SAW | American Safety Equipment Corp. | Nov 16, 1976 | SESE |
| [K760957](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZH/K760957.md) | SURGICAL RECIPROCATING SAW | American Safety Equipment Corp. | Nov 15, 1976 | SESE |

## Top Applicants

- American Safety Equipment Corp. — 2 clearances
- Dentatus USA , Ltd. — 1 clearance
- Osada Electric Co., Ltd. — 1 clearance

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

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