Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010728558

FEI Number

3010728558

Entity Name

3shape inc

City/State/Country

New Providence, NJ, US

Establishment Address

430 Mountain Avenue, Suite 205, New Providence, NJ 07974, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K200100

PMA Number

N/A

All Registered Proprietary Names

L1P-1F Implant Studio Trios 5 (L1P-1F) Abutment designer 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 Abutment Design

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2022-09-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-11-25
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2025-04-07
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
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
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2020-11-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3005940400	3Shape A/S	Copenhagen Hovedstaden, DK

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)

Similar Registrations

Registration Number	Establishment Name	Location
3015172511	3Shape Poland Sp. zo.o	Szczecin Zachodniopomorskie, PL
3015193486	3Shape Inc.	Morrisville, NC, US
3014980444	AIOBIO CO., LTD.	Seongnam-si Gyeonggi, KR
3032734659	Carl Zeiss Meditec (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
3015729	A-dec, Inc.	Newberg, OR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010728558. Last updated year: 2026. Please use registration number 3010728558 when referencing this establishment in official correspondence.