PREMIUM Implant Systems SHELTA Implant Systems

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 Implant Systems Shelta Implant Systems.

Pre-market Notification Details

Device IDK162004
510k NumberK162004
Device Name:PREMIUM Implant Systems SHELTA Implant Systems
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-20
Decision Date2016-12-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D7701279473 K162004 000
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