← Product Code [EJL](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL) · K873698

# STERILIZED DENTAL BIT PACKAGING (K873698)

_Florida Diamond Instruments Corp. · EJL · Dec 3, 1987 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL/K873698

## Device Facts

- **Applicant:** Florida Diamond Instruments Corp.
- **Product Code:** [EJL](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL.md)
- **Decision Date:** Dec 3, 1987
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL/K873698](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJL/K873698)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com