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FDA 510(k) Application Details - K182780
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K182780
Device Name
Material, Tooth Shade, Resin
Applicant
S&C Polymer Silicon- und Composite Spezialitaeten GmbH
Robert-Bosch-Str. 2
Elmshorn 25335 DE
Other 510(k) Applications for this Company
Contact
Christian Boettcher
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2018
Decision Date
07/03/2019
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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