FDA 510(k) Application Details - K210789

Device Classification Name Locator, Root Apex

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510(K) Number K210789
Device Name Locator, Root Apex
Applicant Meta Systems Co., Ltd.
#1214-18, Sicox tower 12F, 484, Dunchon-daero, Jungwon-gu
Seongnam-si 13229 KR
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Contact Hyejin Park
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Regulation Number 000.0000

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Classification Product Code LQY
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Date Received 03/16/2021
Decision Date 10/20/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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