Dental Device Guide
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Manufacturer registered with FDA

Carestream Dental LLC

Atlanta, GA, United States. Lists 6 dental device types with FDA across 3 registered establishments, and holds 11 510(k) clearances as applicant.

FDA owner/operator10056540Foreign exporterManufacturerSpecification developer
Device types listed
6
Brands and models
110
510(k) clearances
112008–2020
Markets registered in
16317 registrations outside the US
Establishments
3France, United Kingdom, United States
2008: 32010: 12011: 12012: 12014: 12015: 12018: 12020: 2200020102020

510(k) clearances per year, 2000–2026

Registered in 16 markets

Where regulators' registries name Carestream Dental LLC as the manufacturer or the registration holder of a device.

All markets
United States: 6 device types listedCanada: 55 registrationsCosta Rica: 43 registrationsTaiwan: 40 registrationsColombia: 28 registrationsEuropean Union: 24 registrationsSaudi Arabia: 23 registrationsSouth Korea: 21 registrationsSerbia: 19 registrationsUnited Kingdom: 16 registrationsPeru: 14 registrationsAustralia: 13 registrationsChina: 7 registrationsBrazil: 5 registrationsHong Kong: 5 registrationsIsrael: 4 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerCarestream Dental LLC11 clearances2008–2020Below
CanadaHealth CanadaRegistration holderCARESTREAM DENTAL, LLC552006–2025Pure Global AI
Costa RicaMinisterio de SaludManufacturerTrophyTROPHY · Carestream Dental LLC43—Pure Global AI
TaiwanTFDAManufacturerTROPHYCARESTREAM DENTAL LLC · Trophy · +1402005–2021Pure Global AI
ColombiaINVIMARegistration holderCARESTREAM DENTAL LLCTROPHY28—Pure Global AI
European UnionEUDAMEDManufacturerCarestream Dental LLC24—Pure Global AI
Saudi ArabiaSFDAManufacturerCarestream Dental LLC23—Pure Global AI
South KoreaMFDSManufacturerTROPHYTrophy212003–2020Pure Global AI
SerbiaALIMSManufacturerCarestream Dental LLC192021–2026Pure Global AI
United KingdomMHRAManufacturerCarestream Dental LLC16—Pure Global AI
PeruDIGEMIDManufacturerCARESTREAM DENTAL LLC142018–2024Pure Global AI
AustraliaTGAManufacturerCarestream Dental LLC132018–2025Pure Global AI
ChinaNMPARegistration holder锐珂牙科有限公司Carestream Dental LLC7—Pure Global AI
BrazilANVISAManufacturerCARESTREAM DENTAL LLCCARESTREAM DENTAL, LLC.52018–2025Pure Global AI
Hong KongMDDManufacturerCarestream Dental LLC52025–2026Pure Global AI
IsraelAMARManufacturerCarestream Dental LLC4—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Carestream Dental LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Digital Extraoral Source X-Ray SystemMUH · Class 2Dental X-ray unitsMaker
CS 2500PCS 6200CS 7200CS 7600CS 7600 SCAN&GO DEVICECS 7600 SLOT PANELCS 8100CS 8100 3DCS 8100 3D AccessCS 8100 Access
9 more
CS 8100SCCS 8100SC 3DCS 8100SC 3D AccessCS 8100SC AccessCS 8200 3DCS 8200 3D AccessRVG 6500RVG CONNECTSCAN CEPH
2017
Dental Computed Tomography X-RayOAS · Class 2Dental CBCTMaker
CEPHALOSTATCS 8100 3DCS 8100 3D AccessCS 8100SC 3DCS 8100SC 3D AccessCS 8200 3DCS 8200 3D AccessCS 9300CS 9300 SelectCS 9300C
3 more
CS 9300C SelectCS 9600Scan Ceph
2017
Intraoral X-Ray UnitEAP · Class 2Dental X-ray unitsMaker
DENTRA IIIRIOSensor+RVG 142RVG 5200RVG 6200S2
2017
Extraoral with Timer X-Ray UnitEHD · Class 2Dental X-ray unitsMaker
CS 2100CS 2200
2017
X-Ray Film HolderEGZ · Class 1—Lister
CG913CGH99CGL12CGP09CGP10CGS50CGS58CGU20CGV53CGV54
58 more
CI897CI898CI899CI900CI901CI902CI903CI904CI905CI906CIC70CSD BDA32CSD BDA33CSD BDA34CSD IX014CSD IX015CSD IX016HY356HY358HY467HY469HY507HY512HY513HY515HY559HY567HY575HY581HY614HY619HY637Hygienic Sheaths CS 7200 Size 0Hygienic Sheaths CS 7200 Size 1Hygienic Sheaths CS 7600 Size 0Hygienic Sheaths CS 7600 Size 1Hygienic Sheaths CS 7600 Size 2Hygienic Sheaths CS 7600 Size 3Hygienic Sheaths CS 7600 Size 4Hygienic Sheaths size 0Hygienic Sheaths size 1Hygienic Sheaths size 2HZ176HZ177HZ229HZ230HZ231HZ232HZ233HZ234HZ235HZ236JR8687600 Hygienic Sheaths size 07600 Hygienic Sheaths size 17600 Hygienic Sheaths size 27600 Hygienic Sheaths size 37600 Hygienic Sheaths size 4
2025
Operative Dental UnitEIA · Class 1Dental chairs & operative unitsMaker
CS 1200CS 1500
2019

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Carestream Dental LLC as the applicant, including filings under its other names.

Decided510(k)DeviceDevice type
2 Apr 2020K193390CS Model+PNN Orthodontic Software
13 Mar 2020K200183CS 9600OAS Dental Computed Tomography X-Ray
24 May 2018K181136CS 9600OAS Dental Computed Tomography X-Ray
21 Aug 2015K151087CS 8100SC, CS8100SC AccessMUH Digital Extraoral Source X-Ray System
14 Mar 2014K133406CS 8100 3DOAS Dental Computed Tomography X-Ray
22 Jun 2012K120975CS 8100 CS 8100 ACCESSMUH Digital Extraoral Source X-Ray System
18 Aug 2011K103659CS 9300, CS 9300COAS Dental Computed Tomography X-Ray
26 Apr 2010K093478KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEMMUH Digital Extraoral Source X-Ray System
5 Dec 2008K082972KODAK 9500MUH Digital Extraoral Source X-Ray System
29 Apr 2008K080889KODAK 9000C EXTRAORAL IMAGING SYSTEMMUH Digital Extraoral Source X-Ray System
11 Feb 2008K073435KODAK 9000, KODAK 9000 3DMUH Digital Extraoral Source X-Ray System

Some of these clearances are listed with FDA today by another company: Dental Imaging Technologies Corporation (1).

Also lists devices cleared under other names

Carestream Dental LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Carestream Health, Inc. (3), iRay Imaging Technology (Haining) Limited (1), Dexcowin Co., Ltd. (1), Kodak-Trophy (1), Trophy Radiologie (1).

Decided510(k)DeviceApplicantDevice type
21 Apr 2023K230811Digital Intraoral X-Ray SensoriRay Imaging Technology (Haining) LimitedMUH Digital Extraoral Source X-Ray System
26 Oct 2017K173046Cocoon Portable Handheld X-Ray SystemDexcowin Co., Ltd.MUH Digital Extraoral Source X-Ray System
10 Nov 2011K112321CS 1200Carestream Health, Inc.EIA Operative Dental Unit
23 Sep 2011K111649CS 7600Carestream Health, Inc.MUH Digital Extraoral Source X-Ray System
18 Aug 2009K091186KODAK 1500 INTRAORAL CAMERACarestream Health, Inc.EIA Operative Dental Unit
3 Mar 2006K060292KODAK MODELS 2100 AND 2200Kodak-TrophyEHD Extraoral with Timer X-Ray Unit
19 Apr 1995K950532TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHYTrophy RadiologieEAP Intraoral X-Ray Unit

Registered establishments

EstablishmentLocationWhat it does
Carestream Dental LLCFDA reg. 1226003Atlanta, GA, United StatesComplaint file establishment, Specification developer
Carestream Dental Technology Topco LimitedFDA reg. 3014398772London London, City of, United KingdomForeign exporter
TrophyFDA reg. 8020825Marne La Vallee Ile-de-France, FranceManufacturer

Other names on FDA records

Trophy · Carestream Dental Technology Topco Limited

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10056540). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.