FDA 510(k) Application Details - K173207

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K173207
Device Name Implant, Endosseous, Root-Form
Applicant SIC invent AG
Birmannsgasse 3
Basel ch-4055 CH
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Contact Cretia Arlene McNett
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 10/02/2017
Decision Date 04/05/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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