FDA Registration
Active
🇰🇷 South Korea
BioMTA
Reg #: 3009130085
·
FEI: 3009130085
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BioMTA
- Registration Number
- 3009130085
- FEI Number
- 3009130085
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 41, Techno 8-ro, Yuseong-gu
- City
- Daejeon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K102575
Owner / Operator
- Firm Name
- BioMTA
- Operator Number
- 10034152
- Address
- 41, Techno 8-ro, Yuseong-gu
- City
- Daejeon
- State
- KR-30
- Postal Code
- 34028
- Country
- KR
- Correspondent
- Jun-sang Yoo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2013-02-25 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2016-12-22 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2013-02-25 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2010-11-10 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2013-02-25 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2013-02-25 |
Proprietary Names
MTA Syringer
OrthoMTA Carrier
Uitrasonic Endo TIP
OrhtoMTA Compactor
OrthoMTA(Mineral Trioxide Aggregate)
OrthoMTA Mixer
OrthoMTA Needle Tips
MTA Syringer Tips
OrhtoMTA Plugger
RetroMTA-OrthoMTA II
Smart MTA
Establishment Types
Manufacture Medical Device