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U.S. Department of Health and Human Services

510(K) Premarket Notification
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blutube® dental unit water purification cartridge (blutube®); model numbers: wb180, wb90, z3 waterline purification straws, dental unit water purification cartridge ProEdge Dental Products, Inc. k232393 10/27/2023
mighty wire guide wire Merit Medical Systems, Inc. k230418 10/28/2023
mouth guard (atg0603r) Reazeal Corp k231865 11/06/2023
diode laser therapy device Hebei Zhemai Technology Co., Ltd k232709 11/30/2023
clearfil universal bond quick 2 Kuraray Noritake Dental Inc. k231039 12/13/2023
ipl hair removal device (ui06pn, ui06 pl, ui06 jl, ui06 br, ui06 db, ui06 pr, ui06 og, ui06 rd, ui08 br, ui08 db, ui08 bl, ui08 gp, ui08 pn, ui08 re, ui08 wh, ui08 pw, ui07 br, ui07 db, ui07 bl, ui07 gp, ui07 pn, ui07 re, ui07 wh, ui07 pw, ui20 br, ui20 db, ui20 bl, ui20 gp, ui20 pn, ui20 re, ui20 Shenzhen Ulike Smart Electronics Co.,Ltd k233887 01/22/2024
fastep™ pregnancy rapid test strip; fastep™ pregnancy rapid test midstream Assure Tech (Hangzhou) Co., Ltd. k233174 02/05/2024
overjet caries assist-pediatric Overjet, Inc k233738 03/04/2024
msfx mikron cervical anterior plate system Mikron Makina Sanayi ve Ticaret Ltd. Sti. k240484 04/17/2024
easyscreen gastrointestinal parasite detection kit Genetic Signatures Limited k232672 05/29/2024

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