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FDA 510(k) Application Details - K233596
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K233596
Device Name
Material, Tooth Shade, Resin
Applicant
BEGO Bremer GoldschlΣgerei Wilh. Herbst GmbH & Co. KG
Wilhelm-Herbst-Stra▀e 1
Bremen 28359 DE
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Contact
Marcel Mⁿller
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
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More FDA Info for this Product Code
Date Received
11/08/2023
Decision Date
11/09/2023
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
Y
Expedited Review
FDA Source Information for K233596
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