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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 K042756
Device Name ENDOREZ
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Applicant Contact TAMMY LAVERY
Correspondent
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Correspondent Contact TAMMY LAVERY
Regulation Number872.3820
Classification Product Code
KIF  
Date Received10/04/2004
Decision Date 10/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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