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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K965138
Device Name DENTINSENSE B/C
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 Number872.3200
Classification Product Code
KLE  
Date Received12/23/1996
Decision Date 02/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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