Manufacturer registered with FDA
Amedcon Medical Technology (Shenzhen) Co., Ltd.
Shenzhen, China. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 37 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Amedcon Medical Technology (Shenzhen) 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 | Amedcon Medical Technology (Shenzhen) Co., Ltd. | 7 device types | — | Below |
| South Korea | MFDS | Manufacturer | Amedcon Medical Technology (Shenzhen) Co., Ltd.Amedcon Medical Technology(Shenzhen) Co., Ltd. | 6 | 2018–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Amedcon Medical Technology (Shenzhen) 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 Amedcon Medical Technology (Shenzhen) 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Empty Plastic Syringes for dental materials fillingPlastic Capillary tipsPlastic Syringe Caps | 2021 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Dispensing Tips (plastic / metal)Empty Plastic Syringes for dental materials fillingPlastic Intra Oral TipsPlastic Syringe Caps | 2013 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | EZ STENT; Thermoplastic Drill Template Set | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | EZ STENT; EZ Stopper; Thermoplastic Drill Template Set | 2015 |
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 |
|---|---|---|
| AMEDCON MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.FDA reg. 3008493350 | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043791). 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.