SDS1.2 Dental Implant

Implant, Endosseous, Root-form

SDS Swiss Dental Solutions AG

The following data is part of a premarket notification filed by Sds Swiss Dental Solutions Ag with the FDA for Sds1.2 Dental Implant.

Pre-market Notification Details

Device IDK181953
501k NumberK181953
Device Name:SDS1.2 Dental Implant
ClassificationImplant, Endosseous, Root-form
Applicant SDS Swiss Dental Solutions AG Konstanzerstrasse 11 Kreuzlingen,  CH 8280
ContactMartin Chares
CorrespondentMartin Chares
SDS Swiss Dental Solutions AG Konstanzerstrasse 11 Kreuzlingen,  CH 8280
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-23
Decision Date2019-11-20

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