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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
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