Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015193486

FEI Number

3015193486

Entity Name

3Shape Inc.

City/State/Country

Morrisville, NC, US

Establishment Address

2800 Perimeter Park Drive, Suite E, Morrisville, NC 27560, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Trios 5 (L1P-1F) 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 L1P-1F

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	2025-04-07
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2007-12-20
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2022-09-24

Official Correspondent

David Rothkopf

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
3015172511	3Shape Poland Sp. zo.o	Szczecin Zachodniopomorskie, PL
3005940400	3Shape A/S	Copenhagen Hovedstaden, DK
3010728558	3shape inc	New Providence, NJ, US

Similar Registrations

Registration Number	Establishment Name	Location
3010728558	3shape inc	New Providence, NJ, US
3015172511	3Shape Poland Sp. zo.o	Szczecin Zachodniopomorskie, PL
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 3015193486. Last updated year: 2026. Please use registration number 3015193486 when referencing this establishment in official correspondence.