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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K130476
Device Name ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
Applicant
DENTAL MORELLI
18851 NE 29TH AVE 720
AVENTURA,  FL  33180
Applicant Contact LILIAN LLULL
Correspondent
DENTAL MORELLI
18851 NE 29TH AVE 720
AVENTURA,  FL  33180
Correspondent Contact LILIAN LLULL
Regulation Number872.3640
Classification Product Code
OAT  
Date Received02/25/2013
Decision Date 01/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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