The following data is part of a premarket notification filed by 3shape A/s with the FDA for Ortho System.
| Device ID | K161884 |
| 510k Number | K161884 |
| Device Name: | Ortho System |
| Classification | Mouthguard, Prescription |
| Applicant | 3Shape A/S Holmens Kanal 7 Copenhagen, DK 1060 |
| Contact | Hanne Nielsen |
| Correspondent | Hanne Nielsen 3Shape A/S Holmens Kanal 7 Copenhagen, DK 1060 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-11 |
| Decision Date | 2017-04-19 |