Ora-Aid
Oral Wound Dressing
TBM Corporation
The following data is part of a premarket notification filed by Tbm Corporation with the FDA for Ora-aid.
Pre-market Notification Details
| Device ID | K211851 |
| 510k Number | K211851 |
| Device Name: | Ora-Aid |
| Classification | Oral Wound Dressing |
| Applicant | TBM Corporation B-301, 313 Cheomadangwagi-ro, Buk-gu Gwangju, KR 61008 |
| Contact | Jaewoong Jung |
| Correspondent | Milly Milly KMC, Inc. Room No. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, KR 08390 |
| Product Code | OLR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-15 |
| Decision Date | 2022-01-11 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800026800347 | K211851 | 000 |
| 08800026800408 | K211851 | 000 |
| 08800026800149 | K211851 | 000 |
Trademark Results [Ora-Aid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORA-AID 97646538 not registered Live/Pending |
TBM Corporation 2022-10-25 |
 ORA-AID 87490499 not registered Live/Pending |
TBM Corporation 2017-06-15 |
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