FDA 510(k) Application Details - K113092

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K113092
Device Name Abutment, Implant, Dental, Endosseous
Applicant ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD, CA 92008-7308 US
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Contact JEREMY MARKOVICH
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 10/19/2011
Decision Date 01/23/2012
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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