← Product Code [EBZ](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ) · K880392

# ORTHOLUX VISIBLE LIGHT CURING UNIT (K880392)

_Unitek Corp. · EBZ · Apr 7, 1988 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K880392

## Device Facts

- **Applicant:** Unitek Corp.
- **Product Code:** [EBZ](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ.md)
- **Decision Date:** Apr 7, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6070
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K880392](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K880392)

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