Manufacturer registered with FDA
Huile Denture Technology (Hong Kong) Co Limited
HONG KONG, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 26 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Huile Denture Technology (Hong Kong) 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 | Huile Denture Technology (Hong Kong) Co Limited | 4 device types | — | Below |
| Australia | TGA | Manufacturer | Huile Denture Technology (Hong Kong) Co Limited | 6 | 2023–2024 | 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 Huile Denture Technology (Hong Kong) 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 |
|---|---|---|---|---|
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | Clear aligner | 2019 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | arylic denturesE.max crown/bridgemetal framework denturesPorcelain fused to metal crown/bridgesValplastzirconia crown/bridges | 2019 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | arylic dentures | 2020 |
| Preformed CrownELZ · Class 1 | — | Maker | E.max crown/bridgePorcelain fused to metal crown/bridgeszirconia crown/bridges | 2020 |
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 |
|---|---|---|
| HUILE DENTURE TECHNOLOGY(HONGKONG)CO,LIMITEDFDA reg. 3015353992 | HONG KONG Hong Kong, China | Contract manufacturer, Contract sterilizer, Foreign exporter, Manufacturer, Remanufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060321). 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.