Manufacturer registered with FDA
Beijing Smart Technology Co., Ltd
BEIJING, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 524 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Beijing Smart 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 | Beijing Smart Technology Co., Ltd | 6 device types | — | Below |
| Brazil | ANVISA | Manufacturer | BEIJING SMART TECHNOLOGY CO. LTD. | 13 | 2007–2016 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BEIJING SMART TECHNOLOGY CO., LTDBeijing Smart Technology Co., Ltd. | 5 | 2014–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BEIJING SMART TECHNOLOGY CO.,LTD.BEIJING SMART TECHNOLOGY CO. , LTD | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Beijing Smart Technology Co., LtdBeijing Smart Technology 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 Beijing Smart 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 |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Preformed NiTi Retainer | 2020 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | OrthomechanicsSmart | 2004 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental NeedleIrrigation NeedleNeedle HolderNeedle Tip | 2024 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | OrthomechanicsSmart | 2004 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | OrthomechanicsSmart | 2004 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | smart | 2019 |
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 |
|---|---|---|
| BEIJING SMART TECHNOLOGY CO., LTD.FDA reg. 3004645512 | Beijing, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9065003). 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.