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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 K132825
Device Name RETROMTA-ORTHOMTA II
Applicant
BIOMTA
2651 E CHAPMAN AVE STE 110
FULLERTON,  CA  92833
Applicant Contact Priscilla Chung
Correspondent
BIOMTA
2651 E CHAPMAN AVE STE 110
FULLERTON,  CA  92833
Correspondent Contact Priscilla Chung
Regulation Number872.3820
Classification Product Code
KIF  
Date Received09/09/2013
Decision Date 04/10/2014
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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