Manufacturer registered with FDA

Litu Tech Ltd.

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

FDA owner/operator10096053Manufacturer1 clearance in five years
Device types listed
1
Brands and models
3
510(k) clearances
12024–2024
Markets registered in
1United States
Establishments
1China
2024: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Litu Tech Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Air-Powered HandpieceEFB · Class 1Dental handpiecesMaker
High Speed Air Turbine (Model:Max ST 4H Mini; Max 4H; Max T; Mini Max 45 4H; Mini Max 45; Mini Max QC; Max Torque QC )High Speed Air Turbine (Model:Mini Max Torque; Mini OPT; Mini OPT Torque )High Speed Air Turbine Handpiece (Model: G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
2026

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 Litu Tech Ltd. as the applicant.

Decided510(k)DeviceDevice type
30 Apr 2024K233122High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)EFB Dental Air-Powered Handpiece

Registered establishments

EstablishmentLocationWhat it does
LITU TECH LTD.FDA reg. 3048247380Zhongshan Guangdong, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10096053). 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.