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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 K152956
Device Name Pulp Canal Sealer, Pulp Canal Sealer EWT
Applicant
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact COURTNEY CLARK
Correspondent
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Wendy Garman
Regulation Number872.3820
Classification Product Code
KIF  
Date Received10/07/2015
Decision Date 05/06/2016
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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