Data / Medical devices / South Korea / TBM Corporation
TBM Corporation: FDA-registered device maker in Buk-gu, Gwangju, South Korea, 2 510(k) clearances
TBM Corporation is registered with the FDA (registration 3016096134) in Buk-gu, Gwangju, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 11, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016096134
- Address
- B-301, 313, Cheomdangwagi-ro, Buk-gu, Gwangju, South Korea, 61008
- Owner or operator
- TBM Corporation (10061533)
- Roles
- Manufacturer
- First device listed
- October 27, 2019
- Registered through
- 2026
- Brand names listed
- Augma Shield (model: OB23), Canker Relief (Model: CR12), Curatick (Models: CR12, CR23, CR53), Ora-Aid (models: OB23, OB53), OraCare (Models: CR12, OB23, OB53)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Manufacturer | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | 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 |
|---|---|---|---|---|---|---|
| January 11, 2022 | K211851 | Ora-Aid | OLR | Substantially Equivalent | Tbm Corporation | accessdata.fda.gov |
| September 18, 2019 | K183436 | OraCure | OLR | Substantially Equivalent | Tbm Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Oral Wound Dressing
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Updated January 11, 2022. 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.