NXV · Diagnostic Light, Soft Tissue Detector
Dental · 21 CFR 872.6350 · Class 2
Overview
| Product Code | NXV |
|---|---|
| Device Name | Diagnostic Light, Soft Tissue Detector |
| Regulation | 21 CFR 872.6350 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | G.o.c.c.l.e.s. | Pierrel Pharma S.R.L. | Sep 15, 2015 | SESE |
| K123169 | ORALID | Forward Science, LLC | Mar 13, 2013 | SESE |
| K121282 | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | Addent, Inc. | Jul 24, 2012 | SESE |
| K102083 | VELSCOPE VX | Led Dental, Inc. | Nov 18, 2010 | SESE |
| K101140 | DENTLIGHT ORAL EXAM LIGHT KIT | Dentlight, Inc. | Jul 15, 2010 | SESE |
| K090135 | TRIMIRA IDENTAFI 3000 | Remicalm, LLC | Feb 17, 2009 | SESE |
| K082668 | BIO-SCREEN | Addent, Inc. | Jan 23, 2009 | SESE |
| K082603 | TRIMIRA OCS 3000 | Remicalm, LLC | Dec 12, 2008 | SESE |
| K080043 | VIZILITE EYEWEAR | Zila, Inc. | Apr 4, 2008 | SESE |
| K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | Den-Mat Holdings, LLC | Apr 3, 2008 | SESE |
| K070523 | MODIFICATION TO: VELSCOPE | Led Dental, Inc. | Apr 5, 2007 | SESE |
| K060920 | 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
