Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005940400

FEI Number

3005940400

Entity Name

3Shape A/S

City/State/Country

Copenhagen Hovedstaden, DK

Establishment Address

Holmens Kanal 7, Copenhagen Hovedstaden 1060, DK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

3Shape A/S (Owner Number: 10023901)

Owner / Operator Contact Address

Holmens Kanal 7, Copenhagen K, DK-84 1060, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161884

PMA Number

N/A

All Registered Proprietary Names

Implant Studio Abutment Design Ortho System 3Shape Splint Design Trios 6 3D scanner R500 3D Scanner R700 3D scanner D900L 3D scanner R710 3D scanner R900 3D Scanner R750 3D Scanner D750 3D Scanner R850 3D Scanner R1000 3D Scanner R2000 3D Scanner D1000 3D Scanner D850 3D Scanner D2000 3Shape Anatomy Design E1 scanner E2 Scanner Novux E3 Scanner Novux E1 Scanner Novux D850 Novux D750 Novux D2000 3Shape Dental System TRIOS Scanner E3 Scanner Novux E2 Scanner E4 Scanner TRIOS 3 Wireles TRIOS 4 Trios Interoral Dental System Puffin TRIOS Patient Monitoring Novux E4 Scanner 3D Scanner D700 3D scanner D710 Automate 3D Scanner D800 3D Scanner D810 3D scanner D500 3Shape F8 Trios Move+ Trios Move Pro Trios 3 3D scanner D900 S1P-2 scanning tip 3Shape Ortho System Abutment designer Ortho System 3Shape Ortho System Mouthguard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-11-25
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2020-11-25
PNN	Orthodontic Software	Dental	Class 2	872.5470	2019-12-31
PNN	Orthodontic Software	Dental	Class 2	872.5470	2020-01-23
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2007-12-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-08-30
PNN	Orthodontic Software	Dental	Class 2	872.5470	2016-08-30
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2017-12-01
PNN	Orthodontic Software	Dental	Class 2	872.5470	2018-01-24
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2019-12-31

Official Correspondent

David Rothkopf

US Agent Details

David Rothkopf Business: MEDIcept Email: drothk@aol.com Phone: (508) 2318842

Related Public Records

Same Entity

3Shape A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015193486	3Shape Inc.	Morrisville, NC, US
3015172511	3Shape Poland Sp. zo.o	Szczecin Zachodniopomorskie, PL
3010728558	3shape inc	New Providence, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005940400. Last updated year: 2026. Please use registration number 3005940400 when referencing this establishment in official correspondence.