Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016875543

FEI Number

3016875543

Entity Name

CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No. 26 Yandanghe Road, Xinbei District, Changzhou Jiangsu 213000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou Sifary Medical Technology Co., Ltd. (Owner Number: 10074229)

Owner / Operator Contact Address

No. 26 Yandanghe Road, Xinbei District, Changzhou, CN-JS 213000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CuringPen Dental Curing Light Intraoral Scanner, Helios 600, Helios 500, MyScanner, Helios 680, Helios 560, Helios 700, INNO SCAN HyperLight Portable X-ray Unit Dental Sensors NanoPix1, NanoPix2, NanoPix1.5, Brand: Eighteeth Dental Sensors V-Sensor1, V-Sensor2 Dental Cone-beam Computed Tomography (model: FinScan F350) 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 Z-Up; Z-Down Endodontic Obturation Device, Fast-Fill, Fast-Pack pro Endodontic Obturation Device, Space-Fill, Space-Pack Apex Locator, FindPex Surgical Microscope, Acuvision X Orion SC-M1.4, Orion SC-M1.6, Orion SC-M1.8, Orion D Orion SL-M1.4, Orion SL-M1.6, Orion SL-M1.8 Orion SM-M1.4, Orion SM-M1.6, Orion SM-M1.8 Orion Kit-M1.4, Orion Kit-M1.6, Orion Kit-M1.8 Orion SS-M1.4, Orion SS-M1.6, Orion SS-M1.8 Ultra X SurfyOne 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 ibG2535T, ibG2540T, ibG2545T, ibG2550T, ibG3035T, ibG3040T, ibG3045T, ibG3050T ibT3035T, ibT3040T, ibT3045T, ibT3050T, ibT4035T, ibT4040T, ibT4045T, ibT4050T Surgical Binocular Loupes, ibT5035+, ibT5040+, ibT5045+, ibT5050+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2022-12-02
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2021-11-22
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2023-09-04
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2022-04-14
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2025-08-13
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2021-11-22
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2021-11-22
LQY	Locator, Root Apex	Unknown	Class U	N/A	2026-04-13
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2024-12-25
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2026-04-08
JET	Pick, Massaging	Dental	Class 1	872.6650	2021-11-22
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2021-11-22

Official Correspondent

Jie Zhu

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Changzhou Sifary Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016875543. Last updated year: 2026. Please use registration number 3016875543 when referencing this establishment in official correspondence.