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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 K983037
Device Name ROEKO SEAL
Applicant
ROEKO ULM, ROESCHEISEN GMBH & CO.
100 MAIN ST.
SUITE 120
CONCORD,  MA  01742
Applicant Contact JAMES DELANEY
Correspondent
ROEKO ULM, ROESCHEISEN GMBH & CO.
100 MAIN ST.
SUITE 120
CONCORD,  MA  01742
Correspondent Contact JAMES DELANEY
Regulation Number872.3820
Classification Product Code
KIF  
Date Received08/31/1998
Decision Date 10/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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