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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K992629
Device Name D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
Applicant
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484 -5458
Applicant Contact JOHN DISCKO
Correspondent
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484 -5458
Correspondent Contact JOHN DISCKO
Regulation Number872.3260
Classification Product Code
LBH  
Date Received07/28/1999
Decision Date 10/22/1999
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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