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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Post, Root Canal
510(k) Number K882125
Device Name CENTRIX TRI-LAMINATE POST SYSTEM
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 Number872.3810
Classification Product Code
ELR  
Date Received05/20/1988
Decision Date 08/11/1988
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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