FDA 510(k) Application Details - K223714

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K223714
Device Name Implant, Endosseous, Root-Form
Applicant Adin Dental Implant Systems Ltd.
Alon Tavor Industrial Zone P.O.B 1128
Afula 1811101 IL
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Contact Ilana Lutvak
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 12/12/2022
Decision Date 12/29/2023
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

FDA Source Information for K223714


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