Dental Device Guide
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Not currently registered with FDA under this name

Omron Healthcare, Inc.

Vernon Hills, IL, United States. Named as applicant on 2 dental 510(k) clearances between 1993 and 1993. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
21993–1993
Markets registered in
11605 registrations outside the US
Establishments
0—
1993: 21990200020102020

510(k) clearances per year, 1990–2026

Registered in 11 markets

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

All markets
United States: 2 clearancesEuropean Union: 315 registrationsSaudi Arabia: 90 registrationsCanada: 71 registrationsColombia: 65 registrationsUnited Kingdom: 20 registrationsSerbia: 16 registrationsHong Kong: 14 registrationsAustralia: 11 registrationsIsrael: 2 registrationsCosta Rica: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantOmron Healthcare, Inc.2 clearances1993–1993Below
European UnionEUDAMEDManufacturerOMRON Healthcare Co., Ltd.315—Pure Global AI
Saudi ArabiaSFDAManufacturerOMRON Healthcare Co., Ltd.90—Pure Global AI
CanadaHealth CanadaRegistration holderOMRON HEALTHCARE CO., LTD.OMRON HEALTHCARE INC.711999–2026Pure Global AI
ColombiaINVIMARegistration holderOMRON HEALTHCARE CO., LTDA.OMRON HEALTHCARE CO. LTD · OMRON HEALTHCARE INC · +265—Pure Global AI
United KingdomMHRAManufacturerOMRON HEALTHCARE Co.,Ltd.20—Pure Global AI
SerbiaALIMSManufacturerOMRON HEALTHCARE Co., Ltd.162025–2026Pure Global AI
Hong KongMDDManufacturerOMRON HEALTHCARE Co., Ltd.142025–2026Pure Global AI
AustraliaTGAManufacturerOmron Healthcare Co Ltd112007–2026Pure Global AI
IsraelAMARManufacturerOMRON HEALTHCARE2—Pure Global AI
Costa RicaMinisterio de SaludManufacturerOMRON HEALTHCARE CO. LTD1—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 Omron Healthcare, Inc. as the applicant.

Decided510(k)DeviceDevice type
14 Apr 1993K926247OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005JEQ Powered Toothbrush
14 Apr 1993K926246OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142JEQ Powered Toothbrush

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.