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FDA 510(k) Application Details - K113539
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K113539
Device Name
Implant, Endosseous, Root-Form
Applicant
RIEMSER ARZNEIMITTEL AG
AN DER WIEK 7
GREIFSWALD-INSEL RIEMS 17493 DE
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Contact
CHRISTOPH WAHL
Other 510(k) Applications for this Contact
Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
DZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/30/2011
Decision Date
05/03/2013
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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