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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 K890140
Device Name PHOSPHORIC-ACID ETCHING GEL
Applicant
Centrix, Inc.
30 Stran Rd.
Milford,  CT  06460
Applicant Contact JOHN DISCKO
Correspondent
Centrix, Inc.
30 Stran Rd.
Milford,  CT  06460
Correspondent Contact JOHN DISCKO
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/13/1989
Decision Date 03/29/1989
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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