Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009438612

FEI Number

3009438612

Entity Name

WORLD BIO TECH CO LTD

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

#612, 560, Dunchon-daero, Jungwon-Gu, Seongnam-si Gyeonggi 13230, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

World Bio Tech Co Ltd (Owner Number: 10046396)

Owner / Operator Contact Address

#612, 560, Dunchon-daero, Jungwon-Gu, Seongnam-si, KR-41 13230, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DELICATE Metal Brackets, SELPRO Metal Brackets SELPRO BRACKET BRIGHT BRACKET Ball Hooks, Buttons, Plastic Buttons, Crimpable Stop, Crimpable Hook, Lingual Sheath, Power Hook, Surgical Hook, Button BIJOU Orthodontic Ceramic Bracket AUTOMATIC STRIP, EASY STRIP, OTO STRIP SMART Wires ; NiTi Archwire, Stainless Steel Archwire, Copper NiTi Archwire, Reverse Curve NiTi Archwire Orthodontic Pliers ; Cutters, Utility Pliers, Removing Pliers, Wire Bending Pliers, Tweezers, ETC Elastomerics ; Intraoral Elastics, Power Chain, Ligature Ties, Separators, Thread, Tubing, Rotation Wedge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2020-06-22
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2014-03-18
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2020-06-22
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2017-02-24
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2016-11-27
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2020-06-22
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2020-06-22
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2020-06-22

Official Correspondent

KANG CHANG HEE

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

World Bio Tech 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
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
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
3010462491	DW Lingual Systems GmbH	Bad Essen Lower Saxony, DE
3009257060	Ortho Traction Pads	Norwalk, CT, US
3027343382	UNIVY TECHNOLOGY ADVANCED CO. LTD	Shanghai, CN
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3012232878	SUNSTAR TRADING INTERNATIONAL LIMITED	Kowloon Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009438612. Last updated year: 2026. Please use registration number 3009438612 when referencing this establishment in official correspondence.