Data / Medical devices / United States / 3shape inc

3shape inc: FDA-registered device maker in New Providence, NJ, United States, 9 510(k) clearances

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

3shape inc is registered with the FDA (registration 3010728558) in New Providence, NJ, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 4, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010728558
Address: 430 Mountain Avenue, Suite 205, New Providence, NJ, United States, 07974
Owner or operator: 3Shape A/S (10023901)
Roles: Complaint file establishment
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	Complaint file establishment	accessdata.fda.gov
Light-Induced Fluorescence Caries Detector	NBL	2	Complaint file establishment	accessdata.fda.gov
Orthodontic Software	PNN	2	Complaint file establishment	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Complaint file establishment	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
April 4, 2025	K242103	TRIOS Ready Tip	NBL	Substantially Equivalent	3Shape TRIOS A/S	accessdata.fda.gov
September 16, 2022	K221249	L1P-1F (TRIOS 5)	NBL	Substantially Equivalent	3Shape TRIOS A/S	accessdata.fda.gov
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
January 17, 2018	K171634	Ortho System	PNN	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
October 31, 2014	K141570	IMPLANT STUDIO	LLZ	Substantially Equivalent	3Shape Medical A/S	accessdata.fda.gov

Compare with other makers

Updated April 4, 2025. 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.