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FDA 510(k) Application Details - K141421
Device Classification Name
Crown And Bridge, Temporary, Resin
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510(K) Number
K141421
Device Name
Crown And Bridge, Temporary, Resin
Applicant
RIZHAO HUGE DENTAL INDUSTRY CO., LTD
ROOM 302, NO. 21 BLDG, KAIYU GARDEN, XISHAN SOUTH ROAD
WENZHOU, ZHEJIANG 325000 CN
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HELEN NAN
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Regulation Number
872.3770
More FDA Info for this Regulation Number
Classification Product Code
EBG
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More FDA Info for this Product Code
Date Received
05/30/2014
Decision Date
02/09/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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