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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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dental electrical motor iroot pro ChangZhou BoMedent Medical Technology Co., Ltd. k191276 06/30/2020
chemodent ceramic metal CHEMODENT DENTAL LABORATORY k791005 08/10/1979
statstrap neonatal incubator safety strap, models ss-001, ss-002 CHILDREN'S HEALTH FIRST, INC. k081264 02/13/2009
reprocessed multiple clip appliers CLEAR MEDICAL, INC. k033579 07/11/2005
smartwand-dtx CLEARCOUNT MEDICAL SOLUTIONS k093557 12/18/2009
cool bond light cured bracket adhesive system COLTENE AG k022224 09/18/2002
one coat se bond COLTENE/WHALEDENT INC. k033760 01/23/2004
arix rad radiographic system Compania Mexicana De Radiologia CGR, S.A. DE C.V. k182134 11/26/2018
infrared forehead thermometer (model ir-ft) Comper Chuangxiang (Beijing) Technology Co., Ltd. k191668 10/18/2019
ecom endotracheal cardiac output monitor system CONMED CORPORATION k131765 12/20/2013

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