FDA 510(k) Application Details - K171795

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K171795
Device Name Implant, Endosseous, Root-Form
Applicant Thommen Medical AG
Neckarsulmstrasse 28
Grenchen 2540 CH
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Contact Daniel Snetivy
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 06/16/2017
Decision Date 09/29/2017
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



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