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FDA 510(k) Application Details - K070401
Device Classification Name
Cleanser, Root Canal
More FDA Info for this Device
510(K) Number
K070401
Device Name
Cleanser, Root Canal
Applicant
ESSENTIAL DENTAL SYSTEMS, INC.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
Other 510(k) Applications for this Company
Contact
SUSAN GOLDSTEIN-FALK
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
02/12/2007
Decision Date
07/11/2007
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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