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FDA 510(k) K102973, SILVER DENTAL ARREST, by Cooley Consulting, Inc.

FDA 510(k) K102973, SILVER DENTAL ARREST, by Cooley Consulting, Inc.

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510(K) Number: K102973
Device Name: SILVER DENTAL ARREST
Manufacturer: Cooley Consulting, Inc.
Device Classification Name: Diammine Silver Fluoride Dental Hypersensitivity Varnish
Regulation Number: PHR
Classification Product Code: KXA
Date Received: 10/06/2010
Decision Date: 07/31/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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