Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002966425

FEI Number

3002966425

Entity Name

Funing Meitedental Factory

City/State/Country

Yancheng Jiangsu, CN

Establishment Address

NO.50 INDUSTRIAL PARK YILIN TOWN, FUNING COUNTRY, Yancheng Jiangsu 224421, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Funing Meitedental Factory (Owner Number: 10051484)

Owner / Operator Contact Address

NO.50 INDUSTRIAL PARK YILIN TOWN, FUNING COUNTRY, Yancheng, CN-JS 224421, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic bands, Latex Elastics;Orthodontic elastomeric Orthodontic Wires Dental drills Orthodontic buccal tube Orthodontic Brackets, Lingual Buttons Dental Files Orthodontic pliers Crimpable Hooks Link Pins with drill, Titanium screw post Stainless Steel Expansion Screw Diamond Burs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2016-03-23
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2016-03-23
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2016-03-23
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2016-03-23
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2016-03-23
EMR	File, Periodontic	Dental	Class 1	872.4565	2016-03-23
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2016-03-23
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-03-23
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2016-03-23
EJL	Bur, Dental	Dental	Class 1	872.3240	2016-03-23

Official Correspondent

MAISIE Qiu

US Agent Details

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

Related Public Records

Same Entity

Funing Meitedental Factory

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

Similar Registrations

Registration Number	Establishment Name	Location
3008005217	US ORTHODONTIC PRODUCTS	Norwalk, CA, US
3009491780	Phoenix Orthodontics Inc	Marietta, GA, US
1833132	G & H Wire Company	Franklin, IN, US
9611458	Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, DE
3022296393	FIRST DENTAL SUPPLIES LLC	Winter Garden, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002966425. Last updated year: 2026. Please use registration number 3002966425 when referencing this establishment in official correspondence.