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FDA 510(k) K153249, Pulpdent Solo Flowable Composite with MCP, by Pulpdent Corporation

FDA 510(k) K153249, Pulpdent Solo Flowable Composite with MCP, by Pulpdent Corporation

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510(K) Number: K153249
Device Name: Pulpdent Solo Flowable Composite with MCP
Manufacturer: Pulpdent Corporation
Device Classification Name: Material, Tooth Shade, Resin
Regulation Number: EBF
Classification Product Code: KXA
Date Received: 11/09/2015
Decision Date: 04/01/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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