← Product Code [EBZ](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ) · K002925

# COOLBLU CURING LIGHT (K002925)

_Dental Systems.Com, Inc. · EBZ · Dec 20, 2000 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K002925

## Device Facts

- **Applicant:** Dental Systems.Com, Inc.
- **Product Code:** [EBZ](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ.md)
- **Decision Date:** Dec 20, 2000
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K002925](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K002925)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com