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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K021146
Device Name D/SENSE 1-STEP
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 Number872.3250
Classification Product Code
EJK  
Date Received04/09/2002
Decision Date 07/02/2002
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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