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FDA 510(k) Application Details - K153098
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K153098
Device Name
Implant, Endosseous, Root-Form
Applicant
SOADCO, S.L.
AVGDA. FITER I ROSELL., 4 BIS-LOCAL 2
ESCALDES-ENGORDANY AD-700 AD
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Contact
MARIA MITJANETA
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
10/26/2015
Decision Date
04/08/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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