← Product Code [EJL](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL) · K802988

# JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS (K802988)

_Swiss American Metal Craft Corp. · EJL · Dec 30, 1980 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL/K802988

## Device Facts

- **Applicant:** Swiss American Metal Craft Corp.
- **Product Code:** [EJL](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL.md)
- **Decision Date:** Dec 30, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3240
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL/K802988](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL/K802988)

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