NXVClass II
Diagnostic Light, Soft Tissue Detector
Dental · 21 CFR 872.6350
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
MDR events2All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances12All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
12 clearances for this product code
- Pierrel Pharma S.R.L.Sep 15, 2015
K151630 · G.o.c.c.l.e.s.
- Forward Science, LLCMar 13, 2013
K123169 · ORALID
- Addent, Inc.Jul 24, 2012
K121282 · MICROLUX/DL MICROLUX/BLU BIO/SCREEN
- Led Dental, Inc.Nov 18, 2010
K102083 · VELSCOPE VX
- Dentlight, Inc.Jul 15, 2010
K101140 · DENTLIGHT ORAL EXAM LIGHT KIT
- Remicalm, LLCFeb 17, 2009
K090135 · TRIMIRA IDENTAFI 3000
- Addent, Inc.Jan 23, 2009
K082668 · BIO-SCREEN
- Remicalm, LLCDec 12, 2008
K082603 · TRIMIRA OCS 3000