Ora-Aid
FDA 510(k) clearance K211851 · decided 2022-01-11
Clearance details
- K-number
- K211851
- Device name
- Ora-Aid
- Applicant
- Tbm Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-06-15
- Decision date
- 2022-01-11
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- OLR
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Gwangju, KR
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| Silatrix Oral Gel (K252425) | Sa3, LLC | 2025-10-23 |
| Elemental Granulate (K241283) | Zinkh NV | 2025-01-03 |
| HealiAid Dental Collagen Wound Dressing (K230529) | Maxigen Biotech, Inc. | 2023-11-22 |
| PerioStom Dental Dressing (K221428) | Forward Science, LLC | 2022-12-22 |
| PuraStat-OM (K210211) | 3-D Matrix, Inc. | 2021-10-08 |
| MucoLock Oral Gel (K203091) | Pcca, Inc. | 2021-02-12 |
| Silatrix Oral Gel (K202000) | Sa3, LLC | 2020-11-20 |
Recalls involving this device
No recalls on record reference this clearance.