Dental Device Guide
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Manufacturer registered with FDA

ECOTRON Co., Ltd.

Seoul, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10049861Manufacturer1 clearance in five years
Device types listed
1
Brands and models
1
510(k) clearances
12022–2022
Markets registered in
716 registrations outside the US
Establishments
1South Korea
2022: 120102020

510(k) clearances per year, 2007–2026

Registered in 7 markets

Where regulators' registries name ECOTRON Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedEuropean Union: 9 registrationsPeru: 3 registrationsCosta Rica: 1 registrationsIsrael: 1 registrationsSerbia: 1 registrationsTaiwan: 1 registrations
RegisteredHome: South KoreaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerECOTRON Co., Ltd.1 clearances2022–2022Below
European UnionEUDAMEDManufacturerEcotron Co.,Ltd9—Pure Global AI
PeruDIGEMIDManufacturerECOTRON Co., Ltd.32019–2024Pure Global AI
Costa RicaMinisterio de SaludManufacturerECOTRON CO, LTD1—Pure Global AI
IsraelAMARManufacturerECOTRON Co. Ltd.1—Pure Global AI
SerbiaALIMSManufacturerECOTRON Co., Ltd.12024–2024Pure Global AI
TaiwanTFDAManufacturerEcotron Co., Ltd.12019–2019Pure 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 ECOTRON Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Extraoral with Timer X-Ray UnitEHD · Class 2Dental X-ray unitsMaker
Extraoral source x-ray system DT-703, ProX Go
2022

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 ECOTRON Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
27 Jun 2022K221233DT-703EHD Extraoral with Timer X-Ray Unit

Registered establishments

EstablishmentLocationWhat it does
ECOTRON Co., Ltd.FDA reg. 3011491794Seoul, South KoreaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10049861). 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.