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.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 12024–2024
- Markets registered in
- 1United States
- Establishments
- 1China
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 type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | 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
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LITU TECH LTD.FDA reg. 3048247380 | Zhongshan Guangdong, China | Manufacturer |
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.