SDS2.2 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 Sds2.2 Dental Implant.

Pre-market Notification Details

Device IDK190406
510k NumberK190406
Device Name:SDS2.2 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-21
Decision Date2020-02-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260468255817 K190406 000
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04260468251352 K190406 000
04260468255800 K190406 000
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04260468251512 K190406 000
04260468251505 K190406 000
04260468251499 K190406 000
04260468251482 K190406 000
04260468250256 K190406 000

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