3Shape Implant Studio

System, Image Processing, Radiological

3Shape Medical A/S

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

Pre-market Notification Details

Device IDK202256
510k NumberK202256
Device Name:3Shape Implant Studio
ClassificationSystem, Image Processing, Radiological
Applicant 3Shape Medical A/S Holmens Kanal 7 Copenhagen,  DK Dk-1060
ContactJenny Axel
CorrespondentRafael Aguila
Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 403 Ludlum,  FL  33155
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-10
Decision Date2020-09-09

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