← Product Code [DZJ](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ) · K760960

# SURGICAL WIRE DRIVER (K760960)

_American Safety Equipment Corp. · DZJ · Nov 19, 1976 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K760960

## Device Facts

- **Applicant:** American Safety Equipment Corp.
- **Product Code:** [DZJ](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ.md)
- **Decision Date:** Nov 19, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4120
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K760960](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K760960)

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