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3Shape A/S

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K200100Abutment DesignOctober 7, 2020
K1919113Shape Splint DesignNovember 27, 2019
K180941Ortho SystemOctober 17, 2018
K171634Ortho SystemJanuary 17, 2018
K163677Ortho SystemApril 20, 2017
K161884Ortho SystemApril 19, 2017
K1514553Shape Abutment Designer SoftwareSeptember 6, 2016
K1520863Shape Ortho SystemApril 28, 2016