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FDA 510(k) Application Details - K072555
Device Classification Name
Cleanser, Root Canal
More FDA Info for this Device
510(K) Number
K072555
Device Name
Cleanser, Root Canal
Applicant
ESSENTIAL DENTAL SYSTEMS, INC.
89 LEUNING ST.
SUITE 8
SOUTH HACKENSACK, NJ 07606 US
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Contact
BRIAN RASIMICK
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
09/10/2007
Decision Date
12/13/2007
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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