Manufacturer registered with FDA
Changzhou Sifary Medical Technology Co., Ltd.
Changzhou, China. Lists 11 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 24
- 510(k) clearances
- 42021–2026
- Markets registered in
- 14462 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 14 markets
Where regulators' registries name Changzhou Sifary 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 | Changzhou Sifary Medical Technology Co., Ltd. | 4 clearances | 2021–2026 | Below |
| Canada | Health Canada | Registration holder | CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. | 131 | 2025–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTDCHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. | 99 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Changzhou Sifary Medical Technology Co., Ltd. | 82 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.CHANGZHOU SIFARY MEDICAL TECHNOLOGY Co., Ltd. | 25 | 2021–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Changzhou Sifary Medical Technology Co Ltd | 23 | 2018–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD | 21 | 2020–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Changzhou Sifary Medical Technology Co. , Ltd.Changzhou Sifary Medical Technology Co. Ltd · Changzhou Sifary Medical Technology Co., Ltd. | 19 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Changzhou Sifary Medical Technology Co., Ltd., | 17 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Changzhou Sifary Medical Technology Co., Ltd.CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. | 16 | 2018–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Changzhou Sifary Medical Technology Co., Ltd. | 12 | 2023–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Changzhou Sifary Medical Technology Co., Ltd.Changzhou Sifary Medical Technology Co., Ltd · Changzhou Sifary Medical Technology Co.,Ltd. | 8 | 2019–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Changzhou Sifary Medical Technology Co.,Ltd. | 6 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Changzhou Sifary Medical Technology Co., Ltd.Changzhou Sifary Medical Technology Co.,Ltd | 3 | — | 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 Changzhou Sifary 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 |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | Hand-held Dental X-ray System (HyperLight-M)HyperLight Portable X-ray UnitHyperLight Pro Portable X-ray Unit | 2023 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | Surgical Headlight, Wireless Z, Lux-SFT, Wireless Z+ | 2024 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | CuringPen Dental Curing LightDental Curing light (Model: Kulzer Translux Cure) | 2022 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Endodontic Obturation Device, Fast-Fill, Fast-Pack proEndodontic Obturation Device, Space-Fill, Space-PackZ-Up; Z-Down | 2021 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | E-FLEX, E-FLEX S, E-FLEX BLUE, E-FLEX GOLD, E-FLEX EDGE, E-FLEX RT, E-FLEX REC, E-FLEX ONE, E-FLEX MINIE-STYLE GOLD, E-STYLE BLUE, E-Aurora | 2021 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | E-Connect S Endo Motor With Built-In Apex LocatorZ-Evo | 2021 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | SurfyOneUltra X | 2021 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | Dental Sensors NanoPix1, NanoPix2, NanoPix1.5, Brand: EighteethDental Sensors V-Sensor1, V-Sensor2 | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Orion Kit-M1.4, Orion Kit-M1.6, Orion Kit-M1.8Orion SC-M1.4, Orion SC-M1.6, Orion SC-M1.8, Orion DOrion SL-M1.4, Orion SL-M1.6, Orion SL-M1.8Orion SM-M1.4, Orion SM-M1.6, Orion SM-M1.8Orion SS-M1.4, Orion SS-M1.6, Orion SS-M1.8 | 2026 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Intraoral Scanner, Helios 600, Helios 500, MyScanner, Helios 680, Helios 560, Helios 700, INNO SCAN | 2021 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Lister | Dental Cone-beam Computed Tomography (model: FinScan F350) | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Changzhou Sifary Medical Technology Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Sep 2026 | K260795 | Hand-held Dental X-ray System (HyperLight-M) | EHD Extraoral with Timer X-Ray Unit |
| 1 Sep 2023 | K232068 | HyperLight Portable X-ray Unit | EHD Extraoral with Timer X-Ray Unit |
| 23 Nov 2022 | K221152 | CuringPen Dental Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 29 Jan 2021 | K201993 | E-connect S Endo Motor with built-in Apex Locator | EKX Ac-Powered Direct Drive Handpiece |
Some of these clearances are listed with FDA today by another company: NuSmile, Ltd. (1).
Also lists devices cleared under other names
Changzhou Sifary Medical Technology Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Changzhou Finno Medical Technology Co., Ltd. (1), Iray Technology Taicang , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Jan 2025 | K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 11 Mar 2022 | K220422 | Dental sensors NanoPix1, NanoPix2 | Iray Technology Taicang , Ltd. | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3016875543 | Changzhou Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10074229). 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.