Manufacturer registered with FDA

Liaoning Rachcera Material Technology Co.,Ltd.

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

FDA owner/operator10092165Manufacturer1 clearance in five years
Device types listed
1
Brands and models
1
510(k) clearances
12024–2024
Markets registered in
37 registrations outside the US
Establishments
1China
2024: 120102020

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name Liaoning Rachcera Material Technology Co.,Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedBrazil: 6 registrationsTaiwan: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerLiaoning Rachcera Material Technology Co.,Ltd.1 clearances2024–2024Below
BrazilANVISAManufacturerLIAONING RACHCERA MATERIAL TECHNOLOGY CO.,LTD62023–2026Pure Global AI
TaiwanTFDAManufacturerLiaoning Rachcera Material Technology Co., Ltd.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 Liaoning Rachcera Material Technology Co.,Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker
Dental Lithium Disilicate Glass Ceramic,HT, ML-HT, LT, ML-LT, MT, MO, HO
2024

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 Liaoning Rachcera Material Technology Co.,Ltd. as the applicant.

Decided510(k)DeviceDevice type
5 Dec 2024K242740Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)EIH Porcelain Powder

Registered establishments

EstablishmentLocationWhat it does
LIAONING RACHCERA MATERIAL TECHNOLOGY CO.,LTD.FDA reg. 3034729999Shenyang Liaoning, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10092165). 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.