FDA 510(k) Application Details - K173968

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K173968
Device Name Abutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG
Lochhamer Schlag 6
GrΣfelfing 82166 DE
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Contact Gordon Dodds
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 12/29/2017
Decision Date 07/17/2018
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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