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FDA 510(k) Application Details - K190998
Device Classification Name
Sealant, Pit And Fissure, And Conditioner
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510(K) Number
K190998
Device Name
Sealant, Pit And Fissure, And Conditioner
Applicant
Apex Dental Materials, Inc.
330 Telser Road
Lake Zurich, IL 60047 US
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Contact
Scott Lamerand
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Regulation Number
872.3765
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Classification Product Code
EBC
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More FDA Info for this Product Code
Date Received
04/16/2019
Decision Date
11/08/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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