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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K152826
Device Name NoCord
Applicant
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484
Applicant Contact GREG MOREAU
Correspondent
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484
Correspondent Contact GREG MOREAU
Regulation Number872.3660
Classification Product Code
ELW  
Subsequent Product Code
MVL  
Date Received09/29/2015
Decision Date 05/27/2016
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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