Carestream Dental LLC

FDA Device Registration & Listing · Atlanta, GA, US · Registration 1226003

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1226003
FEI Number
3002522649
Entity Name
Carestream Dental LLC
City/State/Country
Atlanta, GA, US
Establishment Address
3625 Cumberland Boulevard, Suite 700, Atlanta, GA 30339, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Carestream Dental LLC (Owner Number: 10056540)
Owner / Operator Contact Address
3625 Cumberland Boulevard, Suite 700, Atlanta, GA 30339, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K181136
PMA Number
N/A

All Registered Proprietary Names

RVG 6200 RVG 5200 RVG 142 RIOSensor+ S2 DENTRA III CS 7600 SLOT PANEL CS 7600 SCAN&GO DEVICE CS 7600 CS 7200 CS 9300 CEPHALOSTAT CS 9300 Select CS 9300C CS 9300C Select RVG CONNECT RVG 6500 CS OMS Imaging software CS Orthodontic Imaging Software Swissmeda powered by Carestream Dental CS 1500 7600 Hygienic Sheaths size 4 7600 Hygienic Sheaths size 0 CGV53 HY469 Hygienic Sheaths size 0 CGL12 CGP09 CSD BDA33 CSD BDA34 HZ229 CIC70 HY515 CI903 HY567 Hygienic Sheaths size 1 Hygienic Sheaths CS 7200 Size 1 CI900 HZ236 CG913 HZ233 HZ230 JR868 CI906 CI905 HZ231 HY614 HY559 HZ235 CI897 CSD IX014 HY637 CI904 Hygienic Sheaths CS 7600 Size 1 HY619 HY507 HZ177 CGH99 HY513 CI901 Hygienic Sheaths CS 7600 Size 4 CSD IX016 Hygienic Sheaths CS 7600 Size 0 HZ232 CGV54 CSD IX015 HY467 Hygienic Sheaths CS 7600 Size 3 7600 Hygienic Sheaths size 3 HZ176 CGS50 CI902 CSD BDA32 7600 Hygienic Sheaths size 1 HZ234 CI898 CGP10 CGU20 CI899 HY356 7600 Hygienic Sheaths size 2 Hygienic Sheaths CS 7200 Size 0 Hygienic Sheaths CS 7600 Size 2 HY358 HY575 Hygienic Sheaths size 2 CGS58 HY581 HY512 CS 2100 CS 2200 CS 8100SC 3D Access CS 8100 3D Access CS 8100SC 3D CS 8100 3D SCAN CEPH CS 8200 3D Access CS 8200 3D CS 8100 Access CS 8100 CS 7600 CS 7600 Smart Plate Imaging Plate CS 7200 CSD Smart Plate CS Imaging (Version 8) Logicon Caries Detector Imaging Plate CS 7600 Smart Plate CSD Smart Plate CS 9600

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
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2019-02-13
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2017-12-20
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2017-12-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-12-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-05-03
EIA Unit, Operative Dental Dental Class 1 872.6640 2019-02-13
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 2025-07-22
EHD Unit, X-Ray, Extraoral With Timer 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
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2017-12-20
EAM Screen, Intensifying, Radiographic Radiology Class 1 892.1960 2019-02-13
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-01-17
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2017-12-20
IWZ Film, Radiographic Radiology Class 1 892.1840 2026-03-27
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2018-05-29

Official Correspondent

Raven Wildharber

US Agent Details

No US Agent registered (Local establishment).

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
3014398772 Carestream Dental Technology Topco Limited London London, City of, GB
8020825 Trophy Marne La Vallee Ile-de-France, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221008 Shanghai Handy Medical Equipment Co., Ltd. HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) 2022-06-22
K160788 Ray Co., Ltd. RIOScan (RPS500) 2016-04-15
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

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
8020825 Trophy Marne La Vallee Ile-de-France, FR
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 1226003. Last updated year: 2026. Please use registration number 1226003 when referencing this establishment in official correspondence.
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