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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, Root-Form
510(k) Number K062367
Device Name MINISCREWS ANCHORING SYSTEM, M.A.S.
Applicant
Micerium S.P.A.
Via Marconi 83
Avegno, Genoa,  IT 16030
Applicant Contact EUGENIO MICELI
Correspondent
Micerium S.P.A.
Via Marconi 83
Avegno, Genoa,  IT 16030
Correspondent Contact EUGENIO MICELI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/14/2006
Decision Date 12/08/2006
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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