The following data is part of a premarket notification filed by 3shape Medical A/s with the FDA for Implant Studio.
| Device ID | K141570 |
| 510k Number | K141570 |
| Device Name: | IMPLANT STUDIO |
| Classification | System, Image Processing, Radiological |
| Applicant | 3SHAPE MEDICAL A/S HOLMENS KANAL 7 Copenhagen K, DK Dk-1060 |
| Contact | Hanne Nielsen |
| Correspondent | Hanne Nielsen 3SHAPE MEDICAL A/S HOLMENS KANAL 7 Copenhagen K, DK Dk-1060 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2014-10-31 |
| Summary: | summary |