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FDA 510(k) Application Details - K100152
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K100152
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
SIRONA DENTAL SYSTEMS GMBH
FABRIKSTRASSE 31
BENSHEIM D-64625 DE
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Contact
FRITZ KOLLE
Other 510(k) Applications for this Contact
Regulation Number
872.3630
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Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
01/19/2010
Decision Date
10/22/2010
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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