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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 K964174
Device Name MINERAL TRIOXIDE AGGREGATE (MTA)
Applicant
Tulsa Dental Products, Ltd.
8309 Bryant Dr.
Bethesda,  MD  20817
Applicant Contact H. N. DUNNING
Correspondent
Tulsa Dental Products, Ltd.
8309 Bryant Dr.
Bethesda,  MD  20817
Correspondent Contact H. N. DUNNING
Regulation Number872.3820
Classification Product Code
KIF  
Date Received10/18/1996
Decision Date 02/10/1997
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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