FDA 510(k) Application Details - K170354

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K170354
Device Name Abutment, Implant, Dental, Endosseous
Applicant Institut Straumann AG
Peter Merian Weg 12
Basel CH-4002 CH
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Contact Christopher Klaczyk
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 02/06/2017
Decision Date 06/07/2017
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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