Dental Device Guide
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Manufacturer registered with FDA

Lumitex Medical Devices, Inc.

Brecksville, OH, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9000093Contract manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
13175 registrations outside the US
Establishments
1United States

Registered in 13 markets

Where regulators' registries name Lumitex Medical Devices, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedEuropean Union: 140 registrationsCanada: 10 registrationsAustralia: 8 registrationsBrazil: 5 registrationsSouth Korea: 3 registrationsIsrael: 2 registrationsTaiwan: 2 registrationsColombia: 1 registrationsHong Kong: 1 registrationsPeru: 1 registrationsSaudi Arabia: 1 registrationsSerbia: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerLumitex Medical Devices, Inc.1 device types—Below
European UnionEUDAMEDManufacturerLumitex Medical Devices, Inc.140—Pure Global AI
CanadaHealth CanadaRegistration holderLUMITEX MEDICAL DEVICES, INC.102001–2013Pure Global AI
AustraliaTGAManufacturerLumitex Medical Devices Inc82018–2023Pure Global AI
BrazilANVISAManufacturerLUMITEX MEDICAL DEVICES, INC.LUMITEX MEDICAL DEVICES, Inc.52017–2023Pure Global AI
South KoreaMFDSManufacturerLumitex Medical Devices, Inc.Lumitex Medical Devices, Inc32007–2019Pure Global AI
IsraelAMARManufacturerLumitex Medical Devices, Inc.2—Pure Global AI
TaiwanTFDAManufacturerLumitex Medical Devices, Inc.22017–2021Pure Global AI
ColombiaINVIMAManufacturerLUMITEX MEDICAL DEVICES INC1—Pure Global AI
Hong KongMDDManufacturerLumitex Medical Devices, Inc.12025–2025Pure Global AI
PeruDIGEMIDManufacturerLUMITEX MEDICAL DEVICES Inc.12026–2026Pure Global AI
Saudi ArabiaSFDAManufacturerLumitex Medical Devices, Inc1—Pure Global AI
SerbiaALIMSManufacturerLumitex Medical Devices, Inc.12024–2024Pure 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 Lumitex Medical Devices, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Intraoral Phototherapy DeviceSGQ · Class 2—Maker
MuReva OM™
2026

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

Registered establishments

EstablishmentLocationWhat it does
Lumitex Medical Devices, Inc.FDA reg. 1000122810Brecksville, OH, United StatesContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9000093). 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.