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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 K955279
Device Name D-SENSE
Applicant
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484
Applicant Contact JOHN DISCKO
Correspondent
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484
Correspondent Contact JOHN DISCKO
Regulation Number872.3200
Classification Product Code
KLE  
Date Received11/16/1995
Decision Date 12/28/1995
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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