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FDA 510(k) Application Details - K222435
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K222435
Device Name
Material, Tooth Shade, Resin
Applicant
Cosmedent, Inc
401 N Michigan Ave, Suite 2500
Chicago, IL 60611 US
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Contact
Gary Chuven
Other 510(k) Applications for this Contact
Regulation Number
872.3690
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Classification Product Code
EBF
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More FDA Info for this Product Code
Date Received
08/12/2022
Decision Date
10/11/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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