# Bur, Ent, Diamond Coated, Single Use, Reprocessed
> **Product code: NLZ** · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.4140
## Classification
- **FDA Product Code:** NLZ
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 874.4140
- **Review panel:** EN
- **Medical specialty:** Ear, Nose, Throat
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

ENT diamond bur is an accessory to an ENT drill system.  It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NLZ)
---
*AI Analytics · CC0 1.0*