FDA 510(k) Application Details - K250176

Device Classification Name Implant, Endosseous, Root-Form

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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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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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