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FDA 510(k) Application Details - K071919
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K071919
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG)
60 MINUTEMAN ROAD
ANDOVER, MA 01810 US
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Contact
PAIGE SWEENEY
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
07/12/2007
Decision Date
09/26/2007
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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