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FDA 510(k) Application Details - K163171
Device Classification Name
More FDA Info for this Device
510(K) Number
K163171
Device Name
CeraClean
Applicant
Bisco, Inc.
1100 West Irving Park Road
Schaumburg, IL 60193 US
Other 510(k) Applications for this Company
Contact
Ryan Hobson
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PME
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2016
Decision Date
04/14/2017
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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