Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6350](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6350) → NXV — Diagnostic Light, Soft Tissue Detector

# NXV · Diagnostic Light, Soft Tissue Detector

_Dental · 21 CFR 872.6350 · Class 2_

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

## Overview

- **Product Code:** NXV
- **Device Name:** Diagnostic Light, Soft Tissue Detector
- **Regulation:** [21 CFR 872.6350](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6350)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## Identification

An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

## Classification Rationale

Class II.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K151630](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K151630.md) | G.o.c.c.l.e.s. | Pierrel Pharma S.R.L. | Sep 15, 2015 | SESE |
| [K123169](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K123169.md) | ORALID | Forward Science, LLC | Mar 13, 2013 | SESE |
| [K121282](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K121282.md) | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | Addent, Inc. | Jul 24, 2012 | SESE |
| [K102083](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K102083.md) | VELSCOPE VX | Led Dental, Inc. | Nov 18, 2010 | SESE |
| [K101140](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K101140.md) | DENTLIGHT ORAL EXAM LIGHT KIT | Dentlight, Inc. | Jul 15, 2010 | SESE |
| [K090135](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K090135.md) | TRIMIRA IDENTAFI 3000 | Remicalm, LLC | Feb 17, 2009 | SESE |
| [K082668](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K082668.md) | BIO-SCREEN | Addent, Inc. | Jan 23, 2009 | SESE |
| [K082603](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K082603.md) | TRIMIRA OCS 3000 | Remicalm, LLC | Dec 12, 2008 | SESE |
| [K080043](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K080043.md) | VIZILITE EYEWEAR | Zila, Inc. | Apr 4, 2008 | SESE |
| [K073483](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K073483.md) | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | Den-Mat Holdings, LLC | Apr 3, 2008 | SESE |
| [K070523](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K070523.md) | MODIFICATION TO: VELSCOPE | Led Dental, Inc. | Apr 5, 2007 | SESE |
| [K060920](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/NXV/K060920.md) | VELSCOPE | Led Medical Diagnostics, Inc. | Apr 27, 2006 | SESE |

## Top Applicants

- Addent, Inc. — 2 clearances
- Led Dental, Inc. — 2 clearances
- Remicalm, LLC — 2 clearances
- Den-Mat Holdings, LLC — 1 clearance
- Dentlight, Inc. — 1 clearance

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

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