Manufacturer registered with FDA

Dalian Wenjing Wooden Industry Co., Ltd.

Dalian, China. Lists 2 dental device types with FDA across 1 registered establishment.

FDA owner/operator9054326Contract manufacturerManufacturer
Device types listed
2
Brands and models
2
510(k) clearances
0as applicant
Markets registered in
45 registrations outside the US
Establishments
1China

Registered in 4 markets

Where regulators' registries name Dalian Wenjing Wooden Industry Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedBrazil: 2 registrationsEuropean Union: 2 registrationsAustralia: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDalian Wenjing Wooden Industry Co., Ltd.2 device types—Below
BrazilANVISAManufacturerDALIAN WENJING WOODEN INDUSTRY CO., LTD.22024–2024Pure Global AI
European UnionEUDAMEDManufacturerDALIAN WENJING WOODEN INDUSTRY CO.,LTD2—Pure Global AI
AustraliaTGAManufacturerDalian Wenjing Wooden Industry Co Ltd12005–2005Pure 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 Dalian Wenjing Wooden Industry Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker
MIRROR, MOUTH
2023
Roll CottonEFN · Class 1—Maker
COTTON, ROLL
2023

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
DALIAN WENJING WOODEN INDUSTRY CO., LTD.FDA reg. 3003902419DALIAN Liaoning, ChinaContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9054326). 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.