FDA Registration
Active
🇰🇷 South Korea
WORLD BIO TECH CO LTD
Reg #: 3009438612
·
FEI: 3009438612
·
Expires 2026
Products
8
Proprietary Names
9
Establishment Types
1
Classifications
8
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- WORLD BIO TECH CO LTD
- Registration Number
- 3009438612
- FEI Number
- 3009438612
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #612, 560, Dunchon-daero, Jungwon-Gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K120471
Owner / Operator
- Firm Name
- World Bio Tech Co Ltd
- Operator Number
- 10046396
- Address
- #612, 560, Dunchon-daero, Jungwon-Gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13230
- Country
- KR
- Correspondent
- KANG CHANG HEE
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2020-06-22 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2014-03-18 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2020-06-22 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2016-11-27 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2020-06-22 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2020-06-22 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2020-06-22 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2020-06-22 |
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
Niti Closed coil spring, Niti Open coil spring Torquing Spring
Establishment Types
Manufacture Medical Device