3shape A/S
8 clearances · 5 inspections · aggregated across 3 source records
Scorecard
Events per device across the 180-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
180 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| 3Shape Ortho System | 2015-1 | PNN | 05902768365283 | 1 |
| Ortho System | 2017-1 | PNN | 05902729752510 | 1 |
| Splint Design | 1.1.x | PNN | 05902729752954 | 1 |
| Splint Design | R1.0 | PNN | 05902729753555 | 1 |
| 3SHAPE A/S AUTOMATE | 0 | |||
| 3SHAPE ABUTMENT DESIGN | 0 | |||
| 3SHAPE DENTAL SYSTEM | 0 | |||
| 3SHAPE IMPLANT STUDIO | 0 | |||
| 3SHAPE LAB SCANNER | 0 | |||
| 3SHAPE ORTHO SYSTEM | 0 | |||
| 3SHAPE SPLINT DESIGN | 0 | |||
| 3Shape | R900 | NOF | 05902768365122 | 0 |
| 3Shape | R2000 | NOF | 05902768365214 | 0 |
| 3Shape | R850 | NOF | 05902768365191 | 0 |
| 3Shape | R500 | NOF | 05902768365221 | 0 |
| 3Shape | R1000 | NOF | 05902768365207 | 0 |
| 3Shape | D2000 | NOF | 05902768365177 | 0 |
| 3Shape | R750 | NOF | 05902768365184 | 0 |
| 3Shape | D710 | NOF | 05902768365016 | 0 |
| 3Shape | D850 | NOF | 05902768365153 | 0 |
| 3Shape | D800 | NOF | 05902768365023 | 0 |
| 3Shape | D700 | NOF | 05902768365009 | 0 |
| 3Shape | R700 | NOF | 05902768365047 | 0 |
| 3Shape | D900 | NOF | 05902768365078 | 0 |
| 3Shape | D810 | NOF | 05902768365030 | 0 |
| 3Shape | D750 | NOF | 05902768365146 | 0 |
| 3Shape | D1000 | NOF | 05902768365160 | 0 |
| 3Shape | D900L | NOF | 05902768365085 | 0 |
| 3Shape | D500 | NOF | 05902768365313 | 0 |
| 3Shape Anatomy Design | 2016-1 | NOF | 05902768365115 | 0 |
Showing 1–30 of 180Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3005940400 | 3Shape A/S | Copenhagen Hovedstaden, DK | VAI | |
| 3015193486 | 3Shape Inc. | Morrisville, NC, US | NAI | |
| 3015172511 | 3Shape Poland Sp. zo.o | Szczecin Zachodniopomorskie, PL | VAI | |
| 3010728558 | 3shape inc | New Providence, NJ, US | NAI |