# 3Shape Medical A/S

- Location (FDA's records): Copenhagen, DK
- FDA decisions: 3 (2014–2020): 3 510(k) clearances
- Product codes: LLZ (3)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Straumann USA: 3 (https://510kreport.com/company/straumann-usa)
- Materialise Dental NV: 2 (https://510kreport.com/company/materialise-dental)

## Firms that cite its devices most
- 3Diemme, Ltd.: 2 (https://510kreport.com/company/3diemme)
- 3D Industrial Imaging Co., Ltd.: 2 (https://510kreport.com/company/3d-industrial-imaging)
- Exocad GmbH: 1 (https://510kreport.com/company/exocad)
- Atomica Technology, Inc.: 1 (https://510kreport.com/company/atomica-technology)

## Its most-cited devices
- K152078: Implant Studio 2015 (2015), cited by 5
- K141570: Implant Studio (2014), cited by 1
- K202256: 3Shape Implant Studio (2020), cited by 1

## Recent decisions
- K202256: 3Shape Implant Studio (Sep 9, 2020)
- K152078: Implant Studio 2015 (Dec 4, 2015)
- K141570: Implant Studio (Oct 31, 2014)

Source page: https://510kreport.com/company/3shape-medical-a-s