Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017953780

FEI Number

3017953780

Entity Name

WUHU GULI ORTHO CO.,LTD

City/State/Country

Wuhu Anhui, CN

Establishment Address

Nanling Economic Development Zone, Wuhu Anhui 340223, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Wuhu Guli Ortho Co.,Ltd (Owner Number: 10079999)

Owner / Operator Contact Address

Nanling Economic Development Zone, Wuhu, CN-AH 340223, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic elastomeric auxiliaries Orthodontic retainer screw expansion Orthodontic universal lingual retainers Orthodontic buccal tube Orthodontic wax Orthodontic bands Orthodontic Bonding Dental root canal instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2021-01-07
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2021-01-07
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2021-01-07
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2021-01-07
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2021-01-07
KOP	Adhesive, Denture, Karaya	Dental	Class 1	872.3450	2023-11-21
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2021-01-07

Official Correspondent

Shaoyong Ding

US Agent Details

HEWU MA Email: Hewuma@Hotmail.com Phone: (317) 4162074

Related Public Records

Same Entity

Wuhu Guli Ortho 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
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 3017953780. Last updated year: 2026. Please use registration number 3017953780 when referencing this establishment in official correspondence.