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FDA 510(k) Application Details - K230725
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K230725
Device Name
Implant, Endosseous, Root-Form
Applicant
Arum Dentistry Co., Ltd.
23, Gukjegwahak 11-ro, Yuseong-gu
Daejeon 34002 KR
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Contact
Boyeon Lim
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Regulation Number
872.3640
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Classification Product Code
DZE
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More FDA Info for this Product Code
Date Received
03/16/2023
Decision Date
07/01/2023
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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