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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 K142242
Device Name PREMIUM, SHELTA Implant Systems
Applicant
Sweden & Martina S.P.A.
Via Veneto, 10
Due Carrare,  IT 35020
Applicant Contact GLORIANNA ZANGIACOMI
Correspondent
Sweden & Martina S.P.A.
Via Veneto, 10
Due Carrare,  IT 35020
Correspondent Contact GLORIANNA ZANGIACOMI
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/13/2014
Decision Date 02/02/2015
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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