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FDA 510(k) Application Details - K062733
Device Classification Name
Implant, Endosseous, Orthodontic
More FDA Info for this Device
510(K) Number
K062733
Device Name
Implant, Endosseous, Orthodontic
Applicant
DENTAURUM
10 PHEASANT RUN
NEWTOWN, PA 18940 US
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Contact
CHARLES R BELL
Other 510(k) Applications for this Contact
Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
OAT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2006
Decision Date
11/09/2006
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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