FDA 510(k) Application Details - K072730

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K072730
Device Name Abutment, Implant, Dental, Endosseous
Applicant DENTSPLY INTL.
221 WEST PHILADELPHIA STREET
SUITE 60
YORK, PA 17404 US
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Contact HELEN LEWIS
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 09/26/2007
Decision Date 03/27/2008
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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