NobelParallel Conical Connection

Implant, Endosseous, Root-form

Nobel Biocare AB

The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelparallel Conical Connection.

Pre-market Notification Details

Device IDK173418
510k NumberK173418
Device Name:NobelParallel Conical Connection
ClassificationImplant, Endosseous, Root-form
Applicant Nobel Biocare AB Vastra Hamngatan 1 Goteborg,  SE Se-411 17
ContactCharlemagne Chua
CorrespondentCharlemagne Chua
Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda,  CA  92887
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-01
Decision Date2019-02-21
Summary:summary

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