FDA 510(k) Application Details - K173570

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K173570
Device Name Abutment, Implant, Dental, Endosseous
Applicant Surgident Co., Ltd.
#209-210, Woolim Lion's Valley, 27,
Dunchon-daero 457beon-gil, Jungwon-gu
Seongnam-si 13229 KR
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Contact Ju Youn Choi
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 11/20/2017
Decision Date 05/17/2019
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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