Changzhou Sifary Medical Technology Co., Ltd.
Changzhou Jiangsu, CN
CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. appears in FDA device records in Changzhou Jiangsu, CN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Changzhou Sifary Medical Technology Co., Ltd. between 2021 and 2026. The busiest year on record is 2021, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252224 | Apex Locator (FindPex) | LQY | Substantially Equivalent | |
| K232068 | HyperLight Portable X-ray Unit | EHD | Substantially Equivalent | |
| K221152 | CuringPen Dental Curing Light | EBZ | Substantially Equivalent | |
| K201993 | E-connect S Endo Motor with built-in Apex Locator | EKX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016875543 | 3016875543 | CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. | No. 26 Yandanghe Road, Xinbei District, Changzhou Jiangsu 213000 CN | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- EBZActivator, Ultraviolet, For Polymerization
- EKSFile, Pulp Canal, Endodontic
- EKXHandpiece, Direct Drive, Ac-Powered
- EBALight, Surgical Headlight
- LQYLocator, Root Apex
- FSPLoupe, Diagnostic/Surgical
- EPTMicroscope, Surgical
- JETPick, Massaging
- EKRPlugger, Root Canal, Endodontic
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- MUHSystem, X-Ray, Extraoral Source, Digital
- EHDUnit, X-Ray, Extraoral With Timer
- OASX-Ray, Tomography, Computed, Dental
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain