FDA 510(k) Application Details - K073073

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K073073
Device Name Abutment, Implant, Dental, Endosseous
Applicant DENTSPLY INTERNATIONAL, INC.
SUSQUEHANNA COMMERCE CTR., 221
W. PHILADELPHIA ST., 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 10/31/2007
Decision Date 02/12/2008
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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