FDA 510(k) Application Details - K062732

Device Classification Name Implant, Endosseous, Orthodontic

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510(K) Number K062732
Device Name Implant, Endosseous, Orthodontic
Applicant DENTAURUM
10 PHEASANT RUN
NEWTOWN, PA 18940 US
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Contact CHARLES R BELL
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Regulation Number 872.3640

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Classification Product Code OAT
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Date Received 09/13/2006
Decision Date 10/25/2006
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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