Manufacturer registered with FDA
Beijing ZKSK Technology Co., Ltd.
Beijing, 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
- 15201 registrations outside the US
- Establishments
- 1China
Registered in 15 markets
Where regulators' registries name Beijing ZKSK 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 ZKSK Technology Co., Ltd. | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Beijing ZKSK Technology Co., Ltd | 109 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BEIJING ZKSK TECHNOLOGY CO., LTD. | 25 | 2020–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BEIJING ZKSK TECHNOLOGY CO, LTDBEIJING ZKSK TECHNOLOGY CO., LTD · BEIJING ZKSK TECHNOLOGY CO., LTD. | 16 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BEIJING ZKSK TECHNOLOGY CO. LTDBEIJING ZKSK TECHNOLOGY Co., Ltd. | 9 | 2021–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Beijing ZKSK Technology Co., Ltd. | 7 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | Beijing ZKSK Technology Co., Ltd.,Beijing ZKSK Technology Co., Ltd, | 7 | 2025–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Beijing ZKSK Technology Co., LtdBeijing ZKSK Technology Co., Ltd. · Beijing ZKSK Technology CO., Ltd. · +2 | 7 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Beijing ZKSK Technology Co., Ltd.(주)티디엠^Beijing ZKSK Technology Co., Ltd. · Beijing ZKSK Technology Co., Ltd | 5 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Beijing ZKSK Technology Co Ltd | 4 | 2025–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Beijing ZKSK Technology Co., LtdBeijing ZKSK Technology Co., Ltd. | 4 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Beijing ZKSK Technology Co., Ltd. | 4 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Beijing ZKSK Technology Co.,Ltd | 2 | 2024–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Beijing ZKSK Technology Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | BEIJING ZKSK TECHNOLOGY CO., LTD | 1 | 2023–2023 | 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 ZKSK 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental Instrument Kit | 2020 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | The Mouth Mirror | 2020 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Dental Tweezers | 2020 |
| Roll CottonEFN · Class 1 | — | Maker | Absorbent Cotton, Absorbent Cotton Ball, Medical Cotton Swabs | 2020 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Dental Probe | 2020 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Dental Instrument Forceps | 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 |
|---|---|---|
| BEIJING ZKSK TECHNOLOGY CO., LTD.FDA reg. 3014620201 | beijing, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10064072). 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.