← Product Code [EJL](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL) · K842720

# BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL (K842720)

_Penn-Med Technology, Inc. · EJL · May 21, 1985 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL/K842720

## Device Facts

- **Applicant:** Penn-Med Technology, Inc.
- **Product Code:** [EJL](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL.md)
- **Decision Date:** May 21, 1985
- **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/K842720](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL/K842720)

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