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FDA 510(k) Application Details - K190453
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K190453
Device Name
Material, Tooth Shade, Resin
Applicant
VOCO GmbH
Anton-Flettner-Str. 1-3
Cuxhaven 27472 DE
Other 510(k) Applications for this Company
Contact
Th. Plaumann
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
02/25/2019
Decision Date
04/11/2019
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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