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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 K080917
Device Name IROOT SP
Applicant
Innovative Bioceramix, Inc.
1628 W. 75th Ave.
Vancouver, Bc,  CA V6P 6G2
Applicant Contact QUANZU YANG
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number872.3820
Classification Product Code
KIF  
Date Received04/01/2008
Decision Date 04/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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