Manufacturer registered with FDA
World Bio Tech Co Ltd
Seongnam-si, South Korea. Lists 8 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 9
- 510(k) clearances
- 22012–2016
- Markets registered in
- 47 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name World Bio Tech Co Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | World Bio Tech Co Ltd | 2 clearances | 2012–2016 | Below |
| Taiwan | TFDA | Manufacturer | World Bio Tech Co., Ltd.WORLD BIO TECH | 5 | 2012–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | WORLD BIO TECH CO. LTD. | 1 | 2016–2016 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | WORLD BIO TECH CO., LTD. | 1 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What World Bio Tech Co Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | BIJOU Orthodontic Ceramic BracketSELPRO BRACKET BRIGHT BRACKET | 2014 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | SMART Wires ; NiTi Archwire, Stainless Steel Archwire, Copper NiTi Archwire, Reverse Curve NiTi Archwire | 2020 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Elastomerics ; Intraoral Elastics, Power Chain, Ligature Ties, Separators, Thread, Tubing, Rotation Wedge | 2020 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Ball Hooks, Buttons, Plastic Buttons, Crimpable Stop, Crimpable Hook, Lingual Sheath, Power Hook, Surgical Hook, Button | 2020 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Niti Closed coil spring, Niti Open coil spring Torquing Spring | 2020 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | AUTOMATIC STRIP, EASY STRIP, OTO STRIP | 2016 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | DELICATE Metal Brackets, SELPRO Metal Brackets | 2020 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic Pliers ; Cutters, Utility Pliers, Removing Pliers, Wire Bending Pliers, Tweezers, ETC | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names World Bio Tech Co Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 May 2016 | K152167 | BIJOU Orthodontic Ceramic Bracket | NJM Orthodontic Ceramic Bracket |
| 4 Jun 2012 | K120471 | MACH BRACKETS BRIGHT BRACKETS | NJM Orthodontic Ceramic Bracket |
Some of these clearances are listed with FDA today by another company: Rmo, Inc. (1), Ortho Solutions LC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WORLD BIO TECH CO LTDFDA reg. 3009438612 | Seongnam-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046396). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.