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FDA 510(k) Application Details - K192233
Device Classification Name
Activator, Ultraviolet, For Polymerization
More FDA Info for this Device
510(K) Number
K192233
Device Name
Activator, Ultraviolet, For Polymerization
Applicant
Foshan CICADA Dental Instrument Co., Ltd.
B5-2F, Guangdong New Light Source Industrial Base
Shihan Town, Nanhai
Foshan CN
Other 510(k) Applications for this Company
Contact
Juan Liu
Other 510(k) Applications for this Contact
Regulation Number
872.6070
More FDA Info for this Regulation Number
Classification Product Code
EBZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/19/2019
Decision Date
02/13/2020
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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