FDA 510(k) Application Details - K201668

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K201668
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 Tanja Goetz
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 06/19/2020
Decision Date 06/23/2020
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



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