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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K123824
Device Name VITRO FIL LC
Applicant
Dfl Industria E Comercio SA
18851 NE 29th Ave.
720
Aventura,  FL  33180
Applicant Contact TARA CONRAD
Correspondent
Dfl Industria E Comercio SA
18851 NE 29th Ave.
720
Aventura,  FL  33180
Correspondent Contact TARA CONRAD
Regulation Number872.3275
Classification Product Code
EMA  
Date Received12/12/2012
Decision Date 02/21/2013
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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