FDA 510(k) Application Details - K181477

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K181477
Device Name Implant, Endosseous, Root-Form
Applicant Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd
No.22 Xinyan Road
Yuhang Economic and Technological Development Zone
Hangzhou 311199 CN
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Contact Charles Shen
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 06/05/2018
Decision Date 10/20/2020
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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