Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014398772

FEI Number

3014398772

Entity Name

Carestream Dental Technology Topco Limited

City/State/Country

London London, City of, GB

Establishment Address

C/O Corporation Service Company (Uk) Limited, 5 Churchill Place, 10th Floor,, London London, City of E14 5HU, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

K173622

PMA Number

N/A

All Registered Proprietary Names

Hygienic Sleeves Ear Cones Hygienic Sleeves 3D Bite Block Hygienic Sleeves Bite Block CS 1300 CS 3D Imaging Software RVG 6200 RVG 5200 RVG 142 RIOSensor+ S2 DENTRA III CS 8100 Access CS 8100 Imaging Plate CS 7600 Smart Plate CSD Smart Plate CS 2100 CS 2200 Swissmeda powered by Carestream Dental CS 8100SC Access CS 8100SC CS 8100SC 3D Access CS 8100 3D Access CS 8100SC 3D CS 8100 3D SCAN CEPH CS 8200 3D Access CS 8200 3D CS 9600 Scan Ceph CS 9600 CS 6200 CS Imaging (Version 8)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2017-12-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-12-20
EAP	Unit, X-Ray, Intraoral	Dental	Class 2	872.1810	2017-12-20
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2017-12-20
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2026-03-27
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2017-12-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-05-03
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
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2017-12-20
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2018-05-29
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2020-04-13
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2024-09-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-01-17

Official Correspondent

Raven Wildharber

US Agent Details

Raven Wildharber Business: RA Mgr 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
8020825	Trophy	Marne La Vallee Ile-de-France, FR

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)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014398772. Last updated year: 2026. Please use registration number 3014398772 when referencing this establishment in official correspondence.