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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
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digital dental intra oral sensor, hdi 2000, hdi 2000a RAYENCE CO., LTD k140060 05/13/2014
endlessfiber reusable surgical laser fiber HOGUE SURGICAL LLC k140366 08/15/2014
extricare 2400 npwt system with extricare 2400 npwt pump and extricare npwt foam dressing kit Devon Medical, Inc. k140634 09/19/2014
mpi - molecular precision implant, cpi - cylindrical precision implant, opi - one piece implant, dental abutments and pr DITRON PRECISION LTD k140728 10/17/2014
constellation vision system ALCON RESEARCH, LTD. k141065 08/22/2014
esie apps suite SIEMENS MEDICAL SOLUTIONS USA, INC. k141554 07/11/2014
emg black nitrile medical examination glove powder free ECO MEDI GLOVE SDN. BHD k141579 10/17/2014
inclusive titanium abutments compatible with: zimmer, biomet 3i, and nobel biocare implant PRISMATIK DENTALCRAFT, INC. k142115 11/13/2014
fixtemp cement EXACTA DENTAL DIRECT, INC k142446 06/04/2015
endoskeleton ta ibd and vbr, endoskeleton to and tt, endoskeleton tas, endoskeleton tas, endoskeleton tc, endoskeleton tl TITAN SPINE, LLC k142589 10/17/2014

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