Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006155566

FEI Number

3006155566

Entity Name

YANCHENG DENRUM MEDICAL APPARATUS CO.,LTD.

City/State/Country

Yancheng Jiangsu, CN

Establishment Address

18 Quanchuang Road Touzhao Qingdun, Yancheng Jiangsu 224000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

YANCHENG DENRUM MEDICAL APPARATUS CO.,LTD. (Owner Number: 10046975)

Owner / Operator Contact Address

18 Quanchuang Road Touzhao Qingdun, Yancheng, CN-JS 224000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic Brackets Orthodontic Archwire Face Shield Orthodontic Bands

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2014-06-09
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2015-11-10
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-15
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2014-06-09

Official Correspondent

Paul Huang

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

YANCHENG DENRUM MEDICAL APPARATUS 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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006155566. Last updated year: 2026. Please use registration number 3006155566 when referencing this establishment in official correspondence.