FDA 510(k) Application Details - K112099

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K112099
Device Name Abutment, Implant, Dental, Endosseous
Applicant CONTOUR HEALER, LLC
1117 DITCHLEY ROAD
VIRGINIA BEACH, VA 23451 US
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Contact ALLEN HARDIN WHITE
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 07/22/2011
Decision Date 02/03/2012
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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