NobelClinician, DTX Studio Implant

System, Image Processing, Radiological

NOBEL BIOCARE AB

The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelclinician, Dtx Studio Implant.

Pre-market Notification Details

Device IDK163122
510k NumberK163122
Device Name:NobelClinician, DTX Studio Implant
ClassificationSystem, Image Processing, Radiological
Applicant NOBEL BIOCARE AB VASTRA HAMNGATAN 1 Goteborg,  SE Se-411 17
ContactChalemagne Chua
CorrespondentChalemagne Chua
NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda,  CA  92887
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-08
Decision Date2017-01-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747158809 K163122 000
07332747181944 K163122 000
07332747172829 K163122 000
07332747172805 K163122 000
07332747166101 K163122 000
07332747166125 K163122 000
07332747125153 K163122 000
07332747125160 K163122 000
07332747125177 K163122 000
07332747128963 K163122 000
07332747128970 K163122 000
07332747158793 K163122 000
07332747181937 K163122 000

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