FDA 510(k) Application Details - K063789

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K063789
Device Name Abutment, Implant, Dental, Endosseous
Applicant STRAUMANN USA
60 MINUTEMAN ROAD
ANDOVER, MA 01810 US
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Contact ELAINE ALAN
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 12/21/2006
Decision Date 05/10/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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