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FDA 510(k) Application Details - K151608
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K151608
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
OT MEDICAL GMBH
KONSUL-SMIDT-STR. 8B
BREMEN D-28217 DE
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Contact
Martina Behlau
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/15/2015
Decision Date
04/13/2016
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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