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FDA 510(k) Application Details - K230644
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K230644
Device Name
Material, Tooth Shade, Resin
Applicant
Kulzer, LLC
4315 S. Lafayette Blvd
South Bend, IN 46614 US
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Contact
David Vincent
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
03/08/2023
Decision Date
09/07/2023
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
N
Expedited Review
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