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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
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