Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6070](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6070) → QNF — Laser Activator For Polymerization

# QNF · Laser Activator For Polymerization

_Dental · 21 CFR 872.6070 · Class 2_

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

## Overview

- **Product Code:** QNF
- **Device Name:** Laser Activator For Polymerization
- **Regulation:** [21 CFR 872.6070](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6070)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K232076](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/QNF/K232076.md) | Fibercure | Lumendo AG | Nov 2, 2023 | SESE |
| [K201904](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/QNF/K201904.md) | Monet Curing Laser | CAO Group, Inc. | Nov 24, 2020 | SESE |

## Top Applicants

- CAO Group, Inc. — 1 clearance
- Lumendo AG — 1 clearance

---

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

**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
