← Product Code [EAZ](/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ) · K003995

# SPECULITE/ORALLITE (K003995)

_Trylon Corp. · EAZ · Mar 16, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K003995

## Device Facts

- **Applicant:** Trylon Corp.
- **Product Code:** [EAZ](/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ.md)
- **Decision Date:** Mar 16, 2001
- **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/K003995](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K003995)

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