Manufacturer registered with FDA
Xiamen Antinsky Industry Co., Ltd
Xiamen, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Xiamen Antinsky Industry 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 | Xiamen Antinsky Industry Co., Ltd | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Xiamen Antinsky Industry Co., Ltd | 2 | — | 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 Xiamen Antinsky Industry 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 |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Tray Resin, Ortho Model Resin, Standard Dental Model Resin, Dental Model Resin, Gingiva Resin | 2026 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Castable Dental Resin, Castable Dental Smart Resin | 2026 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Permanent Crown Resin | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Guide Resin | 2026 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Denture Base Resin, Temporary Dental Model Resin | 2026 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | Ortho IBT Resin | 2026 |
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 |
|---|---|---|
| XIAMEN ANTINSKY INDUSTRY CO., LTDFDA reg. 3044921218 | Xiamen Fujian, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095440). 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.