3Shape Splint Design — 3Shape A/S (510(k) K191911)
3Shape Splint Design — 3Shape A/S (510(k) K191911) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: 3Shape Splint Design; Applicant: 3Shape A/S; Clearance track: 510(k).
| Device name | 3Shape Splint Design |
|---|---|
| Applicant | 3Shape A/S |
| Clearance track | 510(k) |
| Submission number | K191911 |
| Decision | Substantially Equivalent |
| Decision date | 2019-11-27 |
| Date received | 2019-07-17 |
| Product code | PNN |
| Device class | 2 |
| Medical specialty | Dental |
| Applicant location | DK |
| Source | openFDA device |
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