Manufacturer registered with FDA
MCTBIO Co., Ltd
Yongin-si, South Korea. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 822 registrations outside the US
- Establishments
- 1South Korea
Registered in 8 markets
Where regulators' registries name MCTBIO 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 | MCTBIO Co., Ltd | 8 device types | — | Below |
| Taiwan | TFDA | Manufacturer | MCTBIOMCTBIO CO., LTD. | 7 | 2018–2022 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | MCTBIO CO., LTDMCTBIO CO., Ltd. | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 韩国麦斯特有限公司MCTBIO | 3 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | MCTBIO, | 3 | 2022–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MCTBIO | 2 | 2019–2019 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MCTBIO Co., Ltd. | 2 | 2017–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | MCTBIO Co., Ltd | 1 | — | 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 MCTBIO 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 Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | BONE TACORTHODONTIC SCREW | 2014 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | DENTAL IMPLANT DRILL | 2012 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | STAR JECTSTAR JECT ENDO | 2017 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR/ Mouth | 2010 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | IRRIGATION SYSTEM | 2010 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | INSTRUMENT/ DENTAL | 2010 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | BONE EXPANDERSPLIT & SINUS MASTER | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ACCESSORIES, IMPLANTAQUA SYSTEMBONE CREST MASTERFixture RemoverGOLD MILLMASAI DRILLNew Bone Chip MakerPREMIUM RIDGE SPLIT KITScrew RemoverSPLIT & SINUS MASTER | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MCTBIOFDA reg. 3008388427 | Yongin-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10032614). 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.