Dental Device Guide
Add your company

Not currently registered with FDA under this name

Carestream Health, Inc.

Atlanta, GA, United States. Named as applicant on 4 dental 510(k) clearances between 2009 and 2012. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
42009–2012
Markets registered in
16646 registrations outside the US
Establishments
0—
2009: 12011: 22012: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 16 markets

Where regulators' registries name Carestream Health, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 4 clearancesCanada: 281 registrationsSaudi Arabia: 146 registrationsTaiwan: 44 registrationsColombia: 41 registrationsSouth Korea: 34 registrationsSerbia: 21 registrationsPeru: 19 registrationsUnited Kingdom: 19 registrationsBrazil: 13 registrationsCosta Rica: 8 registrationsAustralia: 7 registrationsIsrael: 7 registrationsHong Kong: 3 registrationsChina: 2 registrationsEuropean Union: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantCarestream Health, Inc.4 clearances2009–2012Below
CanadaHealth CanadaRegistration holderCARESTREAM HEALTH, INC.2812000–2026Pure Global AI
Saudi ArabiaSFDAManufacturerCarestream Health, INCCarestream Health Inc. · Carestream Health,Inc.146—Pure Global AI
TaiwanTFDAManufacturerCARESTREAM HEALTH, INC.CARESTREAM HEALTH,INC. · Carestream Health, Inc. · +1442004–2025Pure Global AI
ColombiaINVIMAManufacturerCARESTREAM HEALTH, INCCARESTREAM HEALTH INC.41—Pure Global AI
South KoreaMFDSManufacturerCarestream Health, Inc.Carestream health, Inc. · Carestream Health, Inc · +2341999–2026Pure Global AI
SerbiaALIMSManufacturerCarestream Health, Inc.212022–2026Pure Global AI
PeruDIGEMIDManufacturerCARESTREAM HEALTH, INC192015–2026Pure Global AI
United KingdomMHRAManufacturerCarestream Health, Inc.19—Pure Global AI
BrazilANVISAManufacturerCARESTREAM HEALTH INC.CARESTREAM HEALTH, INC. · CARESTREAM HEALTH, INC132008–2026Pure Global AI
Costa RicaMinisterio de SaludManufacturerCARESTREAM HEALTH, INCCarestream Health, Inc.8—Pure Global AI
AustraliaTGAManufacturerCarestream Health Inc72010–2019Pure Global AI
IsraelAMARManufacturerCarestream Health, Inc.Carestream Health Inc · Carestream Health · +17—Pure Global AI
Hong KongMDDManufacturerCarestream Health, Inc.32025–2025Pure Global AI
ChinaNMPARegistration holder锐珂医疗 Carestream Health,Inc.锐珂医疗Carestream Health,Inc.2—Pure Global AI
European UnionEUDAMEDManufacturerCarestream Health, Inc.1—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

510(k) clearances

Clearances on which FDA names Carestream Health, Inc. as the applicant.

Decided510(k)DeviceDevice type
2 Mar 2012K111423CS 1600 INTRAORAL CAMERANBL Light-Induced Fluorescence Caries Detector
10 Nov 2011K112321CS 1200EIA Operative Dental Unit
23 Sep 2011K111649CS 7600MUH Digital Extraoral Source X-Ray System
18 Aug 2009K091186KODAK 1500 INTRAORAL CAMERAEIA Operative Dental Unit

Some of these clearances are listed with FDA today by another company: Carestream Dental LLC (3).

Sources

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 of the most recent filing, which can be a US agent.