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FDA 510(k) Application Details - K141047
Device Classification Name
Liner, Cavity, Calcium Hydroxide
More FDA Info for this Device
510(K) Number
K141047
Device Name
Liner, Cavity, Calcium Hydroxide
Applicant
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN
ROBERT-BOSCH-STRASSE 2
ELMSHORN, SCHLESWIG-HOLSTEIN 25335 DE
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Contact
CHRISTIAN BOETTCHER
Other 510(k) Applications for this Contact
Regulation Number
872.3250
More FDA Info for this Regulation Number
Classification Product Code
EJK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/23/2014
Decision Date
04/14/2015
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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