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FDA 510(k) Application Details - K203641
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
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510(K) Number
K203641
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
EnvisionTEC GmbH
Brusseler Stra▀e 51
Gladbeck D-45968 DE
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Contact
Ruediger van Bernum
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Regulation Number
872.3760
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Classification Product Code
EBI
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More FDA Info for this Product Code
Date Received
12/14/2020
Decision Date
03/30/2021
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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