NXV · Class II · 21 CFR 872.6350

FDA Product Code NXV: Diagnostic Light, Soft Tissue Detector

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

Leading manufacturers include Led Dental, Inc., Remicalm, LLC and Addent, Inc..

12
Total
12
Cleared
87d
Avg days
2006
Since

FDA 510(k) Cleared Diagnostic Light, Soft Tissue Detector Devices (Product Code NXV)

12 devices
1–12 of 12
Cleared Sep 15, 2015
G.o.c.c.l.e.s.
K151630
Pierrel Pharma S.R.L.
Dental · 90d
Cleared Mar 13, 2013
ORALID
K123169
Forward Science, LLC
Dental · 155d
Cleared Jul 24, 2012
MICROLUX/DL MICROLUX/BLU BIO/SCREEN
K121282
Addent, Inc.
Dental · 85d
Cleared Nov 18, 2010
VELSCOPE VX
K102083
Led Dental, Inc.
Dental · 115d
Cleared Jul 15, 2010
DENTLIGHT ORAL EXAM LIGHT KIT
K101140
Dentlight, Inc.
Dental · 84d
Cleared Feb 17, 2009
TRIMIRA IDENTAFI 3000
K090135
Remicalm, LLC
Dental · 27d
Cleared Jan 23, 2009
BIO-SCREEN
K082668
Addent, Inc.
Dental · 133d
Cleared Dec 12, 2008
TRIMIRA OCS 3000
K082603
Remicalm, LLC
Dental · 95d
Cleared Apr 04, 2008
VIZILITE EYEWEAR
K080043
Zila, Inc.
Dental · 87d
Cleared Apr 03, 2008
SAPPHIRE O/E ORAL EXAMINATION SYSTEM
K073483
Den-Mat Holdings, LLC
Dental · 114d
Cleared Apr 05, 2007
MODIFICATION TO: VELSCOPE
K070523
Led Dental, Inc.
Dental · 41d
Cleared Apr 27, 2006
VELSCOPE
K060920
Led Medical Diagnostics, Inc.
Dental · 23d

About Product Code NXV - Regulatory Context