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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 K102575
Device Name ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
Applicant
Do Co., Ltd.
2341 W Crescent Ave. #3
Anaheim,  CA  92801
Applicant Contact Priscilla Chung
Correspondent
Do Co., Ltd.
2341 W Crescent Ave. #3
Anaheim,  CA  92801
Correspondent Contact Priscilla Chung
Regulation Number872.3820
Classification Product Code
KIF  
Date Received09/08/2010
Decision Date 10/29/2010
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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