← Product Code [DYX](/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX) · K820944

# DENTAL ARCH BAR (K820944)

_Unisplint Corp. · DYX · May 5, 1982 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX/K820944

## Device Facts

- **Applicant:** Unisplint Corp.
- **Product Code:** [DYX](/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX.md)
- **Decision Date:** May 5, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4600
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX/K820944](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX/K820944)

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