← Product Code [DYX](/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX) · K910090

# DIMAC WIRES (K910090)

_Instrumentations Unltd. · DYX · Jul 25, 1991 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX/K910090

## Device Facts

- **Applicant:** Instrumentations Unltd.
- **Product Code:** [DYX](/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX.md)
- **Decision Date:** Jul 25, 1991
- **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/K910090](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DYX/K910090)

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