Company ยท DK
3Shape A/S
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2020. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2020 | K200100 | Abutment Design 3Shape A/S, DK | PNP |
| Nov 27, 2019 | K191911 | 3Shape Splint Design 3Shape A/S, DK | PNN |
| Oct 17, 2018 | K180941 | Ortho System 3Shape A/S, DK | PNN |
| Jan 17, 2018 | K171634 | Ortho System 3Shape A/S, DK | PNN |
| Apr 20, 2017 | K163677 | Ortho System 3Shape A/S, DK | PNN |
| Apr 19, 2017 | K161884 | Ortho System 3Shape A/S, DK | MQC |
| Sep 6, 2016 | K151455 | 3Shape Abutment Designer Software 3Shape A/S, DK | PNP |
| Apr 28, 2016 | K152086 | 3Shape Ortho System 3Shape A/S, DK | PNN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||