Manufacturer registered with FDA
BLZ Technology (Wuhan) Co., Ltd.
Wuhan, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 25
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1019 registrations outside the US
- Establishments
- 1China
Registered in 10 markets
Where regulators' registries name BLZ Technology (Wuhan) Co., Ltd. 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 | BLZ Technology (Wuhan) Co., Ltd. | 2 device types | — | Below |
| Brazil | ANVISA | Manufacturer | BLZ TECHNOLOGY (WUHAN) CO., LTD. | 4 | 2023–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | BLZ Technology (Wuhan) Co., Ltd. | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | BLZ Technology (Wuhan) Co., Ltd.BLZ TECHNOLOGY (WUHAN) CO., LTD. | 3 | 2016–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | BLZ Technology (wuhan) Co Ltd | 2 | 2019–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | BLZ Technology (Wuhan) Co. LtdBLZ Technology (Wuhan) Co., Ltd. | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | BLZ Technology (Wuhan) Co., Ltd | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BLZ TECHNOLOGY (WUHAN) Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | BLZ Technology (Wuhan) Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BLZ TECHNOLOGY (WUHAN) CO., LTD. | 1 | 2019–2019 | 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 BLZ Technology (Wuhan) Co., 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DMC-LDMC-MDMC-SScanbody | 2025 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | DS100DS200DS300EDS360+DS400DS500INO100INO100 PlusINO200INO200 Plus 11 moreINO300INO300 PlusINO400INO500Leap 500LS100LS200LS200 PlusLS300NT 510NT 520 | 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 |
|---|---|---|
| BLZ TECHNOLOGY (WUHAN) CO., LTD.FDA reg. 3013137141 | Wuhan Hubei, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053596). 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.