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FDA 510(k) Application Details - K140846
Device Classification Name
Cleanser, Root Canal
More FDA Info for this Device
510(K) Number
K140846
Device Name
Cleanser, Root Canal
Applicant
ESSENTIAL DENTAL SYSTEMS, INC.
89 LEUNING STREET
SUITE 8
SOUTH HACKENSACK, NJ 07606 US
Other 510(k) Applications for this Company
Contact
JEFFREY WAN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KJJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/03/2014
Decision Date
07/25/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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