Manufacturer registered with FDA
BioMTA
Daejeon, South Korea. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 7
- 510(k) clearances
- 12014–2014
- Markets registered in
- 59 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name BioMTA 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 | BioMTA | 1 clearances | 2014–2014 | Below |
| Taiwan | TFDA | Manufacturer | BioMTABIOMTA | 4 | 2015–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | BioMTA | 2 | 2022–2022 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | BIOMTA | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BioMTA | 1 | 2016–2016 | 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 BioMTA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | OrthoMTA(Mineral Trioxide Aggregate)RetroMTA-OrthoMTA IISmart MTA | 2010 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | OrthoMTA Needle Tips | 2013 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | OrthoMTA Carrier | 2013 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | OrhtoMTA Plugger | 2013 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | OrhtoMTA Compactor | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
BioMTA lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Do Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Oct 2010 | K102575 | ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) | Do Co., Ltd. | KIF Root Canal Filling Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BioMTAFDA reg. 3009130085 | Daejeon, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034152). 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.