Miscellaneous devices · 21 CFR 872 Subpart G
Soft Tissue Detector Diagnostic Light
To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities
- Companies listing it
- 66 makers
- Brands and models
- 11
- 510(k) clearances
- 120 in five years
- FDA name
- Diagnostic Light, Soft Tissue Detector
510(k) clearances per year, 1976–2026
Companies that list NXV
6 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Den-Mat Holdings, LLC | United States | Maker | Vizilite Eyewear · ViziLite PRO | 8 | 2026 |
| Addent, Inc. | United States | Maker | Bio/Screen | 7 | 2019 |
| Dentlight, Inc. | United States | Maker | Dentlight Oral Exam Light Kit · DOE · DOE SE · FUSION-DOE | 3 | 2019 |
| Led Dental, Inc. | Canada | Maker | VELscope Vx | 2 | 2010 |
| Forward Science LLC | United States | Maker | OralID | 1 | 2013 |
| Pierrel S.p.A. | Italy | Maker | G.o.c.c.l.e.s. · G.o.c.c.l.e.s. light | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 15 Sep 2015 | K151630 | G.o.c.c.l.e.s. | Pierrel Pharma S.R.L. |
| 13 Mar 2013 | K123169 | ORALID | Forward Science LLC |
| 24 Jul 2012 | K121282 | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | Addent, Inc. |
| 18 Nov 2010 | K102083 | VELSCOPE VX | Led Dental, Inc. |
| 15 Jul 2010 | K101140 | DENTLIGHT ORAL EXAM LIGHT KIT | Dentlight, Inc. |
| 17 Feb 2009 | K090135 | TRIMIRA IDENTAFI 3000 | Remicalm, LLC |
| 23 Jan 2009 | K082668 | BIO-SCREEN | Addent, Inc. |
| 12 Dec 2008 | K082603 | TRIMIRA OCS 3000 | Remicalm, LLC |
| 4 Apr 2008 | K080043 | VIZILITE EYEWEAR | Zila, Inc. |
| 3 Apr 2008 | K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | Den-Mat Holdings, LLC |
| 5 Apr 2007 | K070523 | MODIFICATION TO: VELSCOPE | Led Dental, Inc. |
| 27 Apr 2006 | K060920 | VELSCOPE | Led Medical Diagnostics, Inc. |
Official records: FDA product classification for NXV · 21 CFR 872.6350.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026