TREFOIL System

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 Trefoil System.

Pre-market Notification Details

Device IDK172352
510k NumberK172352
Device Name:TREFOIL System
ClassificationImplant, Endosseous, Root-form
Applicant Nobel Biocare AB BOX 5190, SE-402 26, 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 Received2017-08-03
Decision Date2017-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747102888 K172352 000
07332747102864 K172352 000
07332747161670 K172352 000
07332747161656 K172352 000

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