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FDA 510(k) Application Details - K143758
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K143758
Device Name
Implant, Endosseous, Root-Form
Applicant
CLINICAL HOUSE EUROPE GMBH
OPFIKONERSTRASSE 10
BASSERSDORF 8303 CH
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Contact
Judi Weissinger
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
12/31/2014
Decision Date
08/07/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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