Data / Medical devices / South Korea / BioMTA
BioMTA: FDA-registered device maker in Daejeon, South Korea, 2 510(k) clearances
BioMTA is registered with the FDA (registration 3009130085) in Daejeon, South Korea. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 10, 2014. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009130085
- Address
- 41, Techno 8-ro, Yuseong-gu, Daejeon, South Korea, 34028
- Owner or operator
- BioMTA (10034152)
- Roles
- Manufacturer
- First device listed
- November 10, 2010
- Registered through
- 2027
- Brand names listed
- OrhtoMTA Compactor, OrhtoMTA Plugger, OrthoMTA Carrier, OrthoMTA Needle Tips, OrthoMTA(Mineral Trioxide Aggregate), RetroMTA-OrthoMTA II, Smart MTA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | 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 |
|---|---|---|---|---|---|---|
| April 10, 2014 | K132825 | RETROMTA-ORTHOMTA II | KIF | Substantially Equivalent | Biomta | accessdata.fda.gov |
| October 29, 2010 | K102575 | ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) | KIF | Substantially Equivalent | Do Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Root Canal Filling
- All makers of Instrument, Filling, Plastic, Dental
- All makers of File, Pulp Canal, Endodontic
- All makers of Spreader, Pulp Canal Filling Material, Endodontic
- All makers of Plugger, Root Canal, Endodontic
Updated April 10, 2014. 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.