Data / Medical devices / South Korea / World Bio Tech Co Ltd
World Bio Tech Co Ltd: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 2 510(k) clearances
World Bio Tech Co Ltd is registered with the FDA (registration 3009438612) in Seongnam-si Gyeonggi, South Korea. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 27, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009438612
- Address
- #612, 560, Dunchon-daero Jungwon-Gu, Seongnam-si Gyeonggi, South Korea, 13230
- Owner or operator
- World Bio Tech Co Ltd (10046396)
- Roles
- Manufacturer
- First device listed
- March 18, 2014
- Registered through
- 2026
- Brand names listed
- AUTOMATIC STRIP, EASY STRIP, OTO STRIP, BIJOU Orthodontic Ceramic Bracket, Ball Hooks, Buttons, Plastic Buttons, Crimpable Stop, Crimpable Hook, Lingual Sheath, Power Hook, Surgical Hook, Button, DELICATE Metal Brackets, SELPRO Metal Brackets, Elastomerics ; Intraoral Elastics, Power Chain, Ligature Ties, Separators, Thread, Tubing, Rotation Wedge, Niti Closed coil spring, Niti Open coil spring Torquing Spring, Orthodontic Pliers ; Cutters, Utility Pliers, Removing Pliers, Wire Bending Pliers, Tweezers, ETC, SELPRO BRACKET BRIGHT BRACKET and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Manufacturer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Manufacturer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Manufacturer | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 27, 2016 | K152167 | BIJOU Orthodontic Ceramic Bracket | NJM | Substantially Equivalent | World Bio Tech Co., Ltd. | accessdata.fda.gov |
| June 4, 2012 | K120471 | MACH BRACKETS BRIGHT BRACKETS | NJM | Substantially Equivalent | World Bio Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Band, Elastic, Orthodontic
- All makers of Wire, Orthodontic
- All makers of Spring, Orthodontic
- All makers of Clamp, Wire, Orthodontic
- All makers of Bracket, Metal, Orthodontic
- All makers of Bracket, Ceramic, Orthodontic
Updated May 27, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.