Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System

Abutment, Implant, Dental, Endosseous

Dentalpoint AG

The following data is part of a premarket notification filed by Dentalpoint Ag with the FDA for Zeramex(r) Xt Dental Implant System, Nobelpearl Dental Implant System.

Pre-market Notification Details

Device IDK180184
510k NumberK180184
Device Name:Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Dentalpoint AG Bodenackerstrasse 5 Spreitenbach,  CH 8957
ContactAnja Lieberherr
CorrespondentElizabeth Rose
Mapi USA, Inc. 2343 Alexandria Dirve Suite 100 Lexington,  KY  40504
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-23
Decision Date2018-11-16
Summary:summary

NIH GUDID Devices

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