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FDA 510(k) Application Details - K111541
Device Classification Name
Handpiece, Contra- And Right-Angle Attachment, Dental
More FDA Info for this Device
510(K) Number
K111541
Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant
ESSENTIAL DENTAL SYSTEMS, INC.
89 LEUNING STREET
SUITE 8
SOUTH HACKENSACK, NJ 07606 US
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Contact
JEFFREY WAN
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EGS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2011
Decision Date
03/16/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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