FDA 510(k) Application Details - K162028

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K162028
Device Name Abutment, Implant, Dental, Endosseous
Applicant SWEDEN & MARTINA S.p.A.
via veneto, 10
Due Carrare 35020 IT
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Contact ALESSIA PEZZATO
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 07/22/2016
Decision Date 03/24/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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