PREMIUM - SHELTA Prosthetic Components

Abutment, Implant, Dental, Endosseous

SWEDEN & MARTINA S.p.A.

The following data is part of a premarket notification filed by Sweden & Martina S.p.a. with the FDA for Premium - Shelta Prosthetic Components.

Pre-market Notification Details

Device IDK162028
510k NumberK162028
Device Name:PREMIUM - SHELTA Prosthetic Components
ClassificationAbutment, Implant, Dental, Endosseous
Applicant SWEDEN & MARTINA S.p.A. via Veneto, 10 Due Carrare,  IT 35020
ContactAlessia Pezzato
CorrespondentAlessia Pezzato
SWEDEN & MARTINA S.p.A. via Veneto, 10 Due Carrare,  IT 35020
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-22
Decision Date2017-03-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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