Manufacturer registered with FDA
Hongkong Lute Technology CO., LIMITED
HONG KONG, Hong Kong SAR China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1Hong Kong SAR China
Registered in 3 markets
Where regulators' registries name Hongkong Lute Technology CO., LIMITED as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hongkong Lute Technology CO., LIMITED | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Hong Kong Lute Technology Co., Limited | 4 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hongkong Lute Technology CO., LIMITED | 1 | — | Pure 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 Hongkong Lute Technology CO., LIMITED currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | 360° silicone toothbrush - MCST01 | 2024 |
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | Hand Teether - BY005 BY006 BY007Water-fillable Icy Teethers - BY001 | 2024 |
| Tongue ScraperLCN · Class 1 | — | Maker | Tongue brush suit - MCTB01 | 2024 |
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 |
|---|---|---|
| HONG KONG LUTE TECHNOLOGY CO., LIMITEDFDA reg. 3027605322 | HONG KONG, Hong Kong SAR China | Manufacturer, Private-label distributor, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088201). 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.