Manufacturer registered with FDA
Aidite (Shenzhen) Medical Technology Co., Ltd
Shenzhen, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Aidite (Shenzhen) Medical Technology 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 | Aidite (Shenzhen) Medical Technology Co., Ltd | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Aidite (Shenzhen) Medical Technology Co., Ltd. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Aidite (Shenzhen) Medical Technology Co., Ltd. | 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 Aidite (Shenzhen) Medical Technology 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 | AnalogScanbodyTrueFit Pro 5 | 2025 |
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 |
|---|---|---|
| Aidite (Shenzhen) Medical Technology Co., LtdFDA reg. 3038195217 | Shenzhen Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer, Remanufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093021). 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.