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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K123823
Device Name INTERLIG
Applicant
Angelus Industria DE Productos Odontologicos
18851 NE 29th Ave.
720
Aventura,  FL  33180
Applicant Contact LILIAN LLULL
Correspondent
Angelus Industria DE Productos Odontologicos
18851 NE 29th Ave.
720
Aventura,  FL  33180
Correspondent Contact LILIAN LLULL
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/12/2012
Decision Date 05/31/2013
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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