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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 K161989
Device Name PREMIUM Implant Systems SHELTA Implant Systems
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  
Subsequent Product Code
DZE  
Date Received07/19/2016
Decision Date 02/01/2018
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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