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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 K172560
Device Name PREMIUM ONE 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 Number872.3640
Classification Product Code
DZE  
Date Received08/25/2017
Decision Date 12/21/2017
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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