The following data is part of a premarket notification filed by 3shape A/s with the FDA for 3shape Splint Design.
| Device ID | K191911 |
| 510k Number | K191911 |
| Device Name: | 3Shape Splint Design |
| Classification | Orthodontic Software |
| Applicant | 3Shape A/S Copenhagen, DK 1060 |
| Contact | Shreyosi Chakraborty |
| Correspondent | Shreyosi Chakraborty 3Shape A/S Copenhagen, DK 1060 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-17 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05902729753555 | K191911 | 000 |
| 05902729752954 | K191911 | 000 |