FDA 510(k) Application Details - K160784

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K160784
Device Name Abutment, Implant, Dental, Endosseous
Applicant ALTATEC GMBH
MAYBACHSTRASSE 5
WIMSHEIM D-71299 DE
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Contact COLLEEN BOSWELL
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 03/22/2016
Decision Date 09/14/2016
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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