The following data is part of a premarket notification filed by 3shape A/s with the FDA for 3shape Abutment Designer Software.
| Device ID | K151455 |
| 510k Number | K151455 |
| Device Name: | 3Shape Abutment Designer Software |
| Classification | Dental Abutment Design Software For Dental Laboratory |
| Applicant | 3Shape A/S Holemens Kanal 7 Copenhagen, DK 1060 |
| Contact | Hanne Nielsen |
| Correspondent | Hanne Nielsen 3Shape A/S Holemens Kanal 7 Copenhagen, DK 1060 |
| Product Code | PNP |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2016-09-06 |
| Summary: | summary |