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FDA 510(k) Application Details - K250176
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K250176
Device Name
Implant, Endosseous, Root-Form
Applicant
D.A.N.D. Metal Industries North Ltd
North P.O. B. 51
Migdal Tefen 2495900 IL
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Contact
Yossi Nahon
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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
01/22/2025
Decision Date
04/21/2025
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
FDA Source Information for K250176
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