Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009560013

FEI Number

3009560013

Entity Name

3SHAPE TRIOS 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 Trios (Owner Number: 10040244)

Owner / Operator Contact Address

Holmens Kanal 7, copenhagen, 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 Ready Tip Trios 5 (L1P-1F) L1P-1F TRIOS 3 Wireless TRIOS 4 TRIOS Patient Monitoring Trios Interoral Dental System Trios Move+ 3Shape F8 S1P-2 scanning tip Trios 6 Trios 3 Trios Move Pro Trios Core

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
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2022-09-24
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2012-03-23

Official Correspondent

David Rothkopf

US Agent Details

David Rothkopf Business: MEDIcept Email: drothk@aol.com Phone: (617) 8993449

Related Public Records

Same Entity

3Shape Trios

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3010728558	3shape inc	New Providence, NJ, US
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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009560013. Last updated year: 2026. Please use registration number 3009560013 when referencing this establishment in official correspondence.