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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K162028
Device Name PREMIUM - SHELTA Prosthetic Components
Applicant
Sweden & Martina S.P.A.
Via Veneto, 10
Due Carrare,  IT 35020
Applicant Contact ALESSIA PEZZATO
Correspondent
Sweden & Martina S.P.A.
Via Veneto, 10
Due Carrare,  IT 35020
Correspondent Contact ALESSIA PEZZATO
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/22/2016
Decision Date 03/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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