FDA 510(k) Application Details - K143337

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K143337
Device Name Abutment, Implant, Dental, Endosseous
Applicant ALTATEC GMBH
Maybachstrasse 5
Wimsheim D-71299 DE
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Contact DENNIS PAPPAS
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 11/20/2014
Decision Date 02/17/2015
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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