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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K023818
Device Name FIBERFILL AGP
Applicant
PENTRON CLINICAL TECHNOLOGIES
53 NORTH PLAINS INDUSTRIAL RD.
WALLINGFORD,  CT  06492 -0724
Applicant Contact ANNMARIE TENERO
Correspondent
PENTRON CLINICAL TECHNOLOGIES
53 NORTH PLAINS INDUSTRIAL RD.
WALLINGFORD,  CT  06492 -0724
Correspondent Contact ANNMARIE TENERO
Regulation Number872.3820
Classification Product Code
KIF  
Date Received11/15/2002
Decision Date 04/03/2003
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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