Abutment Design

Dental Abutment Design Software For Dental Laboratory

3Shape A/S

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

Pre-market Notification Details

Device IDK200100
510k NumberK200100
Device Name:Abutment Design
ClassificationDental Abutment Design Software For Dental Laboratory
Applicant 3Shape A/S Holmens Kanal 7 Copenhagen,  DK 1060
ContactJenny Axel
CorrespondentJenny Axel
3Shape A/S Holmens Kanal 7 Copenhagen,  DK 1060
Product CodePNP  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-16
Decision Date2020-10-07

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