Changzhou Sifary Medical Technology Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 14 device types, 15 products catalogued, 4 clearances.
Changzhou Sifary Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Pick, Massaging, Locator, Root Apex and 12 other device types. 14 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
14device types registered with the FDA
15products catalogued under its own name
4510(k) clearances
Registration
| Registered name | CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016875543 |
| FEI number | 3016875543 |
| DUNS | 560366787 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 常州赛乐医疗技术有限公司 |
|---|---|
| Unified social credit code | 91320411MA1MMRC92W |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 26 Yandanghe Road, Xinbei District |
| Postal code | 213000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | Orion SM-M1.4, Orion SM-M1.6, Orion SM-M1.8, Orion SC-M1.4, Orion SC-M1.6, Orion SC-M1.8, Orion D, Orion SS-M1.4, Orion SS-M1.6, Orion SS-M1.8, Orion SL-M1.4, Orion SL-M1.6, Orion SL-M1.8, Orion Kit-M1.4, Orion Kit-M1.6, Orion Kit-M1.8 | 2026 | 70 |
| Activator, Ultraviolet, For Polymerization | Class 2 | CuringPen Dental Curing Light | 2022 | 7 |
| File, Pulp Canal, Endodontic | Class 1 | E-STYLE GOLD, E-STYLE BLUE, E-Aurora, 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 Mini | 2021 | 53 |
| Handpiece, Direct Drive, Ac-Powered | Class 1 | E-Connect S Endo Motor With Built-In Apex Locator, Z-Evo | 2021 | 10 |
| Light, Surgical Headlight | Class 1 | Surgical Headlight, Wireless Z, Lux-SFT, Wireless Z+ | 2024 | 7 |
| Locator, Root Apex | Class U | Apex Locator, FindPex, E-Connect S Endo Motor With Built-In Apex Locator, Z-Evo | 2021 | 8 |
| Loupe, Diagnostic/Surgical | Class 1 | ibT5035T, ibT5040T, ibT5045T, ibT5050T, ibT7235T, ibT7240T, ibT7245T, ibT7250T, Surgical Binocular Loupes, ibG3035D, ibG3040D, ibG3045D, ibG3050D, ibG3035S, ibG3040S, ibG3045S, ibG3050S, Surgical Binocular Loupes, ibG3535D, ibG3540D, ibG3545D, ibG3550D, ibG3535S, ibG3540S, ibG3545S, ibG3550S, ibT5045, Surgical Binocular Loupes, ibT5035+, ibT5040+, ibT5045+, ibT5050+, ibT3035T, ibT3040T, ibT3045T, ibT3050T, ibT4035T, ibT4040T, ibT4045T, ibT4050T, ibG2535T, ibG2540T, ibG2545T, ibG2550T, ibG3035T, ibG3040T, ibG3045T, ibG3050T | 2021 | 15 |
| Microscope, Surgical | Class 1 | Surgical Microscope, Acuvision X | 2024 | 9 |
| Pick, Massaging | Class 1 | SurfyOne, Ultra X | 2021 | 46 |
| Plugger, Root Canal, Endodontic | Class 1 | Z-Up; Z-Down, Endodontic Obturation Device, Fast-Fill, Fast-Pack pro, Endodontic Obturation Device, Space-Fill, Space-Pack | 2021 | 19 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | Intraoral Scanner, Helios 600, Helios 500, MyScanner, Helios 680, Helios 560, Helios 700, INNO SCAN | 2021 | 36 |
| System, X-Ray, Extraoral Source, Digital | Class 2 | Dental Sensors NanoPix1, NanoPix2, NanoPix1.5, Brand: Eighteeth, Dental Sensors V-Sensor1, V-Sensor2 | 2022 | 10 |
| Unit, X-Ray, Extraoral With Timer | Class 2 | HyperLight Portable X-ray Unit, HyperLight Pro Portable X-ray Unit | 2023 | 8 |
| X-Ray, Tomography, Computed, Dental | Class 2 | Dental Cone-beam Computed Tomography (model: FinScan F350) | 2025 | 4 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Eighteeth | FSP | 250 |
| Eighteeth | EKS | 101 |
| Eighteeth | NDP | 16 |
| Eighteeth | EBA | 3 |
| Eighteeth | MUH | 3 |
| Eighteeth | NOF | 2 |
| Eighteeth | EKR | 2 |
| Zarc | EKR | 2 |
| Zarc | EKX | 1 |
| Eighteeth | EKX | 1 |
| Eighteeth | EBZ | 1 |
| Eighteeth | EHD | 1 |
| Eighteeth | JET | 1 |
| Eighteeth | EPT | 1 |
Clearances
4 clearances name Changzhou Sifary Medical Technology Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252224 | 2026-04-08 | LQY | Traditional | This company |
| K232068 | 2023-09-01 | EHD | Traditional | This company |
| K221152 | 2022-11-23 | EBZ | Traditional | This company |
| K201993 | 2021-01-29 | EKX | Traditional | This company |
| K242805 | 2025-01-09 | OAS | Traditional | Changzhou Finno Medical Technology Co., Ltd. |
| K220422 | 2022-03-11 | MUH | Special | Iray Technology Taicang, Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Main products | Root canal treatment systems, Dental imaging equipment, Endodontic motors, Digital impression systems, Dental microscopes |
| Certifications | NMPA, FDA, CE |
| Export markets | 154 countries and regions |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.