Data / Medical devices / Denmark / 3Shape A/S

3Shape A/S: FDA-registered device maker in Copenhagen Hovedstaden, Denmark, 8 510(k) clearances

Name: 3Shape A/S FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

3Shape A/S is registered with the FDA (registration 3005940400) in Copenhagen Hovedstaden, Denmark. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 7, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005940400
Address: Holmens Kanal 7, Copenhagen Hovedstaden, Denmark, 1060
Owner or operator: 3Shape A/S (10023901)
Roles: Manufacturer, Specification developer
First device listed: December 20, 2007
Registered through: 2026
Brand names listed: 3D Scanner D1000, 3D Scanner D2000, 3D Scanner D700, 3D Scanner D750, 3D Scanner D800, 3D Scanner D810, 3D Scanner D850, 3D Scanner R1000 and more

Devices it lists

Device	Product code	Class	Role	Source
Dental Abutment Design Software For Dental Laboratory	PNP	2	Manufacturer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Specification developer	accessdata.fda.gov
Orthodontic Software	PNN	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 7, 2020	K200100	Abutment Design	PNP	Substantially Equivalent	3Shape A/S	accessdata.fda.gov
September 9, 2020	K202256	3Shape Implant Studio	LLZ	Substantially Equivalent	3Shape Medical A/S	accessdata.fda.gov
November 27, 2019	K191911	3Shape Splint Design	PNN	Substantially Equivalent	3Shape A/S	accessdata.fda.gov
October 17, 2018	K180941	Ortho System	PNN	Substantially Equivalent	3Shape A/S	accessdata.fda.gov
January 17, 2018	K171634	Ortho System	PNN	Substantially Equivalent	3Shape A/S	accessdata.fda.gov
April 19, 2017	K161884	Ortho System	MQC	Substantially Equivalent	3Shape A/S	accessdata.fda.gov
September 6, 2016	K151455	3Shape Abutment Designer Software	PNP	Substantially Equivalent	3Shape A/S	accessdata.fda.gov
April 28, 2016	K152086	3Shape Ortho System	PNN	Substantially Equivalent	3Shape A/S	accessdata.fda.gov

Compare with other makers

Updated October 7, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.