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FDA 510(k) Application Details - K123582
Device Classification Name
Handpiece, Direct Drive, Ac-Powered
More FDA Info for this Device
510(K) Number
K123582
Device Name
Handpiece, Direct Drive, Ac-Powered
Applicant
SAEYANG MICROTECH CO., LTD
55 NORTHERN BLVD
GREAT NECK, NY 11021 US
Other 510(k) Applications for this Company
Contact
JIGAR SHAH
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/20/2012
Decision Date
08/16/2013
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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