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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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acry plus, acry lux, acry lux v, acry rock, acry rock v and z-tone preformed plastic denture teeth DENTAL MANUFACTURING S.P.A k013824 01/30/2002
sirolaser advance+ Dentsply Sirona k170500 05/16/2017
attune® porous fixed bearing tibial base, medialized dome patella, and medialized anatomic patella with affixium™ 3dp technology DePuy Ireland UC k202194 11/25/2020
delta xtend reverse shoulder system DePuy Ireland UC k203694 07/22/2021
depuy summit fx cemented hip prosthesis DEPUY ORTHOPAEDICS, INC. k023453 11/13/2002
depuy segmentalspinal system DEPUY, INC. k810329 04/08/1981
adx4000-l, dx3000-l DEXCOWIN CO., LTD k083532 03/10/2009
dca digox-syn ria test DIAGNOSTIC CORP. OF AMERICA k810477 03/11/1981
reagent for determ. creatine phosphokina DIAGNOSTIC SOLUTIONS, INC. k800684 05/28/1980
free testosterone enzymeimmunoassay (eia) kit DIAGNOSTICS BIOCHEM CANADA, INC. k030730 08/18/2003

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