Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020825

FEI Number

7695

Entity Name

Trophy

City/State/Country

Marne La Vallee Ile-de-France, FR

Establishment Address

4 rue F. Pelloutier, CROISSY- BEAUBOURG, Marne La Vallee Ile-de-France 77435, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Carestream Dental LLC (Owner Number: 10056540)

Owner / Operator Contact Address

3625 Cumberland Boulevard, Suite 700, Atlanta, GA 30339, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093478

PMA Number

N/A

All Registered Proprietary Names

RVG 6200 RVG 5200 RVG 142 RIOSensor+ S2 DENTRA III CS 3D Imaging Software Hygienic Sleeves Ear Cones Hygienic Sleeves 3D Bite Block Hygienic Sleeves Bite Block CS 1300 CS 8100 Access CS 8100 CS 9300 CEPHALOSTAT CS 9300 Select CS 9300C CS 9300C Select Logicon Caries Detector CS Imaging (Version 8) CS 8100SC Access CS 8100SC RVG CONNECT RVG 6500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAP	Unit, X-Ray, Intraoral	Dental	Class 2	872.1810	2017-12-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-12-20
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2017-12-20
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2017-12-20
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2017-12-20
MYN	Analyzer, Medical Image	Radiology	Class 2	892.2070	2017-12-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-01-17
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2017-12-20
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2017-12-20

Official Correspondent

Raven Wildharber

US Agent Details

Raven Wildharber Business: Carestream Dental LLC Email: raven.wildharber@CSDental.com Phone: (470) 4818687

Related Public Records

Same Entity

Carestream Dental LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1226003	Carestream Dental LLC	Atlanta, GA, US
3014398772	Carestream Dental Technology Topco Limited	London London, City of, GB

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
1226003	Carestream Dental LLC	Atlanta, GA, US
3015980207	OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS	Ansan-si Gyeonggi, KR
2424472	DENTSPLY LLC	York, PA, US
3014398772	Carestream Dental Technology Topco Limited	London London, City of, GB
3006529712	ZENTECH MANUFACTURING, INC	Baltimore, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020825. Last updated year: 2026. Please use registration number 8020825 when referencing this establishment in official correspondence.