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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K973257
Device Name VERSAETCH
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 Number872.3690
Classification Product Code
EBF  
Date Received08/29/1997
Decision Date 11/17/1997
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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