DTX Studio Design

Dental Abutment Design Software For Dental Laboratory

Nobel Biocare AB

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

Pre-market Notification Details

Device IDK181932
510k NumberK181932
Device Name:DTX Studio Design
ClassificationDental Abutment Design Software For Dental Laboratory
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 CodePNP  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-19
Decision Date2019-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747157932 K181932 000
07332747157949 K181932 000
07332747180756 K181932 000
07332747173314 K181932 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.