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FDA 510(k) Application Details - K143486
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device
510(K) Number
K143486
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
VOCO GMBH
ANTON-FLETTNER-STR 1-3
CUXHAVEN D-27472 DE
Other 510(k) Applications for this Company
Contact
M.Th. Plaumann
Other 510(k) Applications for this Contact
Regulation Number
872.3760
More FDA Info for this Regulation Number
Classification Product Code
EBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/08/2014
Decision Date
01/07/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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