# Polymer, Ear, Nose And Throat, Synthetic, Absorbable
> **Product code: NHB** · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3620
## Classification
- **FDA Product Code:** NHB
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 874.3620
- **Review panel:** EN
- **Medical specialty:** Ear, Nose, Throat
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs.  This generic type of device is made of absorbable synthetic polymer materials.

## Market data
- **Cleared 510(k) submissions:** 15
- **Registered establishments:** 36
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NHB)
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