Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015060193

FEI Number

3015060193

Entity Name

CHENGDU SANI MEDICAL EQUIPMENT CO.,LTD.

City/State/Country

Chengdu Sichuan, CN

Establishment Address

No. 408, Tengfei 4th Road, Southwest Airport Economic Development Zone, Shuangliu District, Chengdu Sichuan 610207, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Chengdu Sani Medical Equipment CO.,LTD. (Owner Number: 10058743)

Owner / Operator Contact Address

No. 408, Tengfei 4th Road, Southwest Airport Economic Development Zone, Shuangliu District, Chengdu, CN-SC 610207, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Electric Torque Driver Gutta Percha Points, Model: Taper 02/03/04/06/F1-F5/Small/Primary/Large/XF-M, Gutta Percha Bar Isolation clothing Orthodontic Wires Palatal Expander Face shield Face Mask S3 Rotary Endo Files, KID Rotary Endo Files, S PRO Rotary Endo Files BS Rotary Endo Files, U File, Super C Root Canal Files, REAMERS Root Canal Files, K Files Root Canal Files, H Files Root Canal Files, TAPER FILE Rotary Endo Files, G3 Rotary Endo Files, Super Pass Rotary Endo Files, Absorbent Paper Points, Model: Taper 02/03/04/06/F1-F5/Small/Primary/Large/XF-M Blue Diamond Bur Carbide Bur; Stainless Bur

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECT	Driver, Band, Orthodontic	Dental	Class 1	872.4565	2024-02-28
EKM	Gutta-Percha	Dental	Class 1	872.3850	2021-01-28
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-11
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2024-05-13
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2025-05-11
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-11
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-14
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2018-10-24
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2021-01-28
EJL	Bur, Dental	Dental	Class 1	872.3240	2018-10-24

Official Correspondent

qiuping Zhang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Chengdu Sani Medical Equipment 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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015060193. Last updated year: 2026. Please use registration number 3015060193 when referencing this establishment in official correspondence.