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FDA 510(k) Application Details - K221695
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K221695
Device Name
Material, Tooth Shade, Resin
Applicant
3M Company ESPE Dental Products
2510 Conway Avenue
St. Paul, MN 55144 US
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Contact
Regina Feferman-Savvateev
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
06/10/2022
Decision Date
06/13/2022
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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