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510(k) K073483

Device
SAPPHIRE O/E ORAL EXAMINATION SYSTEM
Applicant
DEN-MAT HOLDINGS, LLC
510(k) number
K073483
Product code
NXV  
Decision
Substantially Equivalent (SESE)
Decision date
2008-04-03
Date received
2007-12-11
Regulation
872.6350
Classification name
Diagnostic Light, Soft Tissue Detector
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ALAN MATTHEWS
Address
2727 Skyway Dr. Santa Maria CA US 93455 93455

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NXV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151630G.o.c.c.l.e.s.Pierrel Pharma S.R.L.2015-09-15
K123169ORALIDForward Science, LLC2013-03-13
K121282MICROLUX/DL MICROLUX/BLU BIO/SCREENAddent, Inc.2012-07-24
K102083VELSCOPE VXLed Dental, Inc.2010-11-18
K101140DENTLIGHT ORAL EXAM LIGHT KITDentlight, Inc.2010-07-15
K090135TRIMIRA IDENTAFI 3000Remicalm, LLC2009-02-17
K082668BIO-SCREENAddent, Inc.2009-01-23
K082603TRIMIRA OCS 3000Remicalm, LLC2008-12-12
K080043VIZILITE EYEWEARZila, Inc.2008-04-04
K070523MODIFICATION TO: VELSCOPELed Dental, Inc.2007-04-05
K060920VELSCOPELed Medical Diagnostics, Inc.2006-04-27

Legacy Summary#

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FDA Review#

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