3Shape Ortho System

Orthodontic Software

3Shape A/S

The following data is part of a premarket notification filed by 3shape A/s with the FDA for 3shape Ortho System.

Pre-market Notification Details

Device IDK152086
510k NumberK152086
Device Name:3Shape Ortho System
ClassificationOrthodontic Software
Applicant 3Shape A/S Holmens Kanal 7 Copenhagen,  DK Dk-1060
ContactHanne Nielsen
CorrespondentHanne Nielsen
3Shape A/S Holmens Kanal 7 Copenhagen,  DK Dk-1060
Product CodePNN  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-27
Decision Date2016-04-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05902768365283 K152086 000

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