← Product Code [EAZ](/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ) · K912997

# MINIFLEX AND PERSONAL UNIT (K912997)

_Dabi-Atlante America Corp. · EAZ · Oct 30, 1991 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K912997

## Device Facts

- **Applicant:** Dabi-Atlante America Corp.
- **Product Code:** [EAZ](/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ.md)
- **Decision Date:** Oct 30, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4630
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K912997](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K912997)

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