FDA 510(k) Application Details - K173116

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K173116
Device Name Implant, Endosseous, Root-Form
Applicant KJ Meditech Co., Ltd
21, Cheomdan Venture-ro,
40 Beon-gil, Buk-gu
Gwangju 500-470 KR
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Contact Hyukki Moon
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 09/29/2017
Decision Date 06/28/2018
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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