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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
Date
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dd cubex2 DENTAL DIREKT GMBH k150196 03/26/2015
430 torque high-speed handpiece series - 430 swl torque high speed handpiece, 430 sw torque high speed handpiece DENTALEZ, INC. k153411 04/08/2016
dentlight oral exam light kit DENTLIGHT INC. k101140 07/15/2010
fluoride varnish DENTSPLY INTL. k031932 09/15/2003
3.5 mm side effect electrode with integrated handpiece, model 227301, 3.5 mm angled side effect electrode with integrate DEPUY MITEK, A JOHNSON & JOHNSON COMPANY k082643 12/19/2008
gryphon p br ds anchor w/orthocord,gryphon p br anchor w/orthocord, model 210813,210814 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY k090124 03/11/2009
depuy corail amt hip prosthesis DePuy Orthopaedics, Inc. k192946 11/26/2019
standard wheelchair platform DESIGN SPECIFIC LTD k073565 02/06/2009
instrument tray pad DEVON INDUSTRIES, INC. k771124 10/28/1977
liaison® folate Diasorin Inc. k192586 05/06/2020

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