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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diammine Silver Fluoride Dental Hypersensitivity Varnish
510(k) Number K102973
FOIA Releasable 510(k) K102973
Device Name SILVER DENTAL ARREST
Applicant
Cooley Consulting, Inc.
531 Chisholm Trail
Wyoming,  OH  45215
Applicant Contact WILLIAM COOLEY
Correspondent
Cooley Consulting, Inc.
531 Chisholm Trail
Wyoming,  OH  45215
Correspondent Contact WILLIAM COOLEY
Regulation Number872.3260
Classification Product Code
PHR  
Date Received10/06/2010
Decision Date 07/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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