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FDA 510(k) Applications for Medical Device Product Code "NXV"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K082668
ADDENT, INC.
BIO-SCREEN
01/23/2009
K121282
ADDENT, INC.
MICROLUX/DL MICROLUX/BLU BIO/SCREEN
07/24/2012
K073483
DEN-MAT HOLDINGS, LLC
SAPPHIRE O/E ORAL EXAMINATION SYSTEM
04/03/2008
K101140
DENTLIGHT INC.
DENTLIGHT ORAL EXAM LIGHT KIT
07/15/2010
K123169
FORWARD SCIENCE LLC
ORALID
03/13/2013
K070523
LED DENTAL INC.
MODIFICATION TO: VELSCOPE
04/05/2007
K102083
LED DENTAL INC.
VELSCOPE VX
11/18/2010
K060920
LED MEDICAL DIAGNOSTICS INC.
VELSCOPE
04/27/2006
K151630
PIERREL PHARMA S.R.L.
G.o.c.c.l.e.s.
09/15/2015
K090135
REMICALM, LLC
TRIMIRA IDENTAFI 3000
02/17/2009
K082603
REMICALM, LLC
TRIMIRA OCS 3000
12/12/2008
K080043
ZILA, INC.
VIZILITE EYEWEAR
04/04/2008
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