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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