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FDA 510(k) Applications Submitted by Jeffrey Wan
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150020
01/06/2015
Irritrol, EDS Combo-Rinse
ESSENTIAL DENTAL SYSTESM, INC.
K140846
04/03/2014
EDS COMBO-RINSE
ESSENTIAL DENTAL SYSTEMS, INC.
K171096
04/13/2017
Fujifilm Diathermic Slitter (FlushKnife)
FUJIFILM Medical Systems U.S.A., Inc.
K171207
04/25/2017
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
FUJIFILM Medical Systems U.S.A., Inc.
K101504
06/01/2010
TI-CORE FLOW
ESSENTIAL DENTAL SYSTEMS, INC.
K111541
06/02/2011
ENDO-EXPRESS (R) HANDPIECE
ESSENTIAL DENTAL SYSTEMS, INC.
K132609
08/20/2013
EDS ULTRASONIC TIPS
ESSENTIAL DENTAL SYSTEMS, INC.
K152691
09/21/2015
EDS Universal Cement
ESSENTIAL DENTAL SYSTEMS, INC
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