FDA 510(k) Application Details - K181900

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K181900
Device Name Handpiece, Air-Powered, Dental
Applicant Foshan CICADA Dental Instrument Co., Ltd.
B5-2F, Guangdong New Light Source Industrial Base
Shihan, Nanhai District
Foshan 528247 CN
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Contact Juan Liu
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 07/16/2018
Decision Date 12/09/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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