# 3Shape A/S

- Location (FDA's records): Copenhagen, DK
- FDA decisions: 8 (2016–2020): 8 510(k) clearances
- Product codes: PNN (5), PNP (2), MQC (1)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 27 (4 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
- Ulab Systems, Inc.: 1 (https://510kreport.com/company/ulab-systems)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- Cadent, Inc.: 1 (https://510kreport.com/company/cadent)

## Firms that cite its devices most
- Laon Medi, Inc.: 2 (https://510kreport.com/company/laon-medi)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)
- Trophy: 1 (https://510kreport.com/company/trophy)
- Orchestrate 3D: 1 (https://510kreport.com/company/orchestrate-3d)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Institut Straumann AG: 1 (https://510kreport.com/company/institut-straumann)
- Clearadvance, LLC: 1 (https://510kreport.com/company/clearadvance)
- Braces on Demand, Inc.: 1 (https://510kreport.com/company/braces-on-demand)

## Its most-cited devices
- K152086: 3Shape Ortho System (2016), cited by 8
- K171634: Ortho System (2018), cited by 6
- K180941: Ortho System (2018), cited by 5
- K151455: 3Shape Abutment Designer Software (2016), cited by 4
- K200100: Abutment Design (2020), cited by 3
- K161884: Ortho System (2017), cited by 1

## Recent decisions
- K200100: Abutment Design (Oct 7, 2020)
- K191911: 3Shape Splint Design (Nov 27, 2019)
- K180941: Ortho System (Oct 17, 2018)
- K171634: Ortho System (Jan 17, 2018)
- K163677: Ortho System (Apr 20, 2017)
- K161884: Ortho System (Apr 19, 2017)
- K151455: 3Shape Abutment Designer Software (Sep 6, 2016)
- K152086: 3Shape Ortho System (Apr 28, 2016)

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