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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K123761
Device Name VITA ENAMIC STAINS
Applicant
Innovation Meditech GmbH
3150 E. Birch St.
Brea,  CA  92821
Applicant Contact ELIZABETH WOLFSEN
Correspondent
Innovation Meditech GmbH
3150 E. Birch St.
Brea,  CA  92821
Correspondent Contact ELIZABETH WOLFSEN
Regulation Number872.3310
Classification Product Code
EBD  
Date Received12/07/2012
Decision Date 03/01/2013
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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