Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004704962

FEI Number

3004704962

Entity Name

ASTAR ORTHODONTICS INC.

City/State/Country

SHANGHAI, CN

Establishment Address

Suite 1503, Lidu Mansion, No. 500 South Zhongshan Road Section 1,, SHANGHAI 200023, CN

Establishment Type(s)

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

Owner / Operator

ASTAR ORTHODONTICS INC. (Owner Number: 9065482)

Owner / Operator Contact Address

Suite 1503, Lidu Mansion, # 500 South Zhongshan Road Section 1, SHANGHAI, CN-SH 200023, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ligature elastic, mouse shape ligature elastic, cat shape ligature elastic, flower shape lingual retainer, lower lingual retainer, upper Niti wire Ligature wire Stainless Steel wire stainless steel photo mirrors, lingual stainless steel photo mirrors, single polished, set stainless steel photo mirrors, buccal stailess steel photo mirrors, double polished,set stainless steel photo mirror, oclussional ligature cutter, bird beak pliers, Omega loop forming pliers, Tweed loop forming pliers, turret, End cutter band

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2004-08-02
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2007-11-29
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2004-08-02
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2007-11-29
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2007-11-29
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2007-11-29
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2004-08-02

Official Correspondent

BENSON WANG

US Agent Details

Fang Lin Business: SEF International Company Email: flin14372@yahoo.com Phone: (703) 4089356

Related Public Records

Same Entity

ASTAR ORTHODONTICS INC.

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
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
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

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 3004704962. Last updated year: 2026. Please use registration number 3004704962 when referencing this establishment in official correspondence.