Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005537733

FEI Number

3005537733

Entity Name

WUXI TP ORTHODONTICS MATERIAL CO., LTD.

City/State/Country

WUXI Jiangsu, CN

Establishment Address

L2, A2 BUILDING, LIYUAN ECONOMIC DEVELOPMENT ZONE, WUXI Jiangsu 214072, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TP ORTHODONTICS, INC. (Owner Number: 1815540)

Owner / Operator Contact Address

100 CENTER PLAZA, --, La Porte, IN 46350, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elastomeric Seperators Tru-Force Bump-R-Sleeve tubing Zing String E-Chain Sep-A-Rings Super Slick Elastomeric Ligature ties Elastomeric tubing Mini Stix TPO Elastic thread E-Links Elastomeric thread TPO Latex Elastics Elastomeric ligature ties Elastics Heat Activated Nickel-Titanuim Preformed Archwire TP Original Wire Aesthetic Nickel-Titanuim Preformed Archwire Multi-Strand Preformed Archwire Nickel-Titanuim Preformed Archwire Pre-torqued Preformed Archwire Looped Preformed Archwire Stainless Steel Preformed Archwire Lip Bumper TiMolium Preformed Archwire Bio-Arch Wires Aesthetic Stainless Steel Preformed Archwire Ligature Wire on Spool Preformed Ligature Ties Lip Bumper Coated Lip Bumper with Pads Stainless Steel Straight Archwire VELA Archwire System Bow-Flex Archwire Miscellaneous Wires Tip-Edge Plus NX Tip-Edge Rx-I Begg Metal Bracket Nu-Edge, Straight Edge, Tip Edge, Advant- Edge, Twin-Edge Bracket 256 Begg Bracket Nu-Edge NX Nu-Edge SL Pre-coated Metal bracket Nu-Edge SL Metal Bracket Tip-Edge Plus Metal Nu-Edge II Cobalt Chromium Twin bracket MESIO-DISTAL REDUCER Straight shooter Ligature Applicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2006-01-06
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2006-01-06
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2006-01-06
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2006-01-06
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2014-04-28

Official Correspondent

No official correspondent registered.

US Agent Details

Cristiane Muller Business: TP Orthodontics Email: cristiane.muller@tportho.com Phone: (219) 7852591

Related Public Records

Same Entity

TP ORTHODONTICS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1815540	TP ORTHODONTICS, INC.	LA PORTE, IN, US

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 3005537733. Last updated year: 2026. Please use registration number 3005537733 when referencing this establishment in official correspondence.