FDA 510(k) Application Details - K211978

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K211978
Device Name Implant, Endosseous, Root-Form
Applicant JJ Medical Co., Ltd.
Daeryung Techno Town 3 409 Gasan-Dong, 115,
Gasan Digital 2-Ro, Geumcheon-Gu
Seoul 08505 KR
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Contact Sun Jae Lee
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 06/25/2021
Decision Date 01/05/2022
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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