← Product Code [DZP](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP) · K913651

# MANI DIA-BURS (K913651)

_The Lahr Consulting Group, Inc. · DZP · Jan 14, 1992 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K913651

## Device Facts

- **Applicant:** The Lahr Consulting Group, Inc.
- **Product Code:** [DZP](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP.md)
- **Decision Date:** Jan 14, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4535
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K913651](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K913651)

**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