Device class
Unclassified
Regulation —
Total clearances
14
2020-05-27 → 2026-08-05
Definition
What is Oral Wound Dressing
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Sa3, LLC
|
2 |
1 |
2025-10-23 |
|
Tbm Corporation |
1 |
0 |
2022-01-11 |
|
Medizin Produkte Neustadt GmbH (Mpn) |
1 |
1 |
2025-12-18 |
|
Synedgen, Inc. |
1 |
0 |
2020-05-27 |
|
USpharma, Ltd. |
1 |
1 |
2026-06-15 |
|
HCS Innovation, LLC |
1 |
1 |
2026-08-05 |
|
Emanate Biomedical |
1 |
1 |
2026-07-29 |
|
Forward Science, LLC |
1 |
0 |
2022-12-22 |
|
Maxigen Biotech, Inc.
|
1 |
0 |
2023-11-22 |
|
3-D Matrix, Inc.
|
1 |
0 |
2021-10-08 |
|
Pcca, Inc. |
1 |
0 |
2021-02-12 |
|
Zinkh NV |
1 |
0 |
2025-01-03 |
|
MoleculeX Co., Ltd. |
1 |
1 |
2026-05-21 |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-05 |
K260120 |
HCS Innovation, LLC
|
NaturaJel Oral Wound Care Kit |
| 2026-07-29 |
K251908 |
Emanate Biomedical
|
Emanate Tray |
| 2026-06-15 |
K260126 |
USpharma, Ltd.
|
Curajel Oral Gel |
| 2026-05-21 |
K253816 |
MoleculeX Co., Ltd.
|
MuCover (proposed name) Oral Wound Dressing |
| 2025-12-18 |
K253758 |
Medizin Produkte Neustadt GmbH (Mpn)
|
Dental Cone; Dental Sponge |
| 2025-10-23 |
K252425 |
Sa3, LLC
|
Silatrix Oral Gel |
| 2025-01-03 |
K241283 |
Zinkh NV
|
Elemental Granulate |
| 2023-11-22 |
K230529 |
Maxigen Biotech, Inc.
|
HealiAid Dental Collagen Wound Dressing |
| 2022-12-22 |
K221428 |
Forward Science, LLC
|
PerioStom Dental Dressing |
| 2022-01-11 |
K211851 |
Tbm Corporation
|
Ora-Aid |
| 2021-10-08 |
K210211 |
3-D Matrix, Inc.
|
PuraStat-OM |
| 2021-02-12 |
K203091 |
Pcca, Inc.
|
MucoLock Oral Gel |
| 2020-11-20 |
K202000 |
Sa3, LLC
|
Silatrix Oral Gel |
| 2020-05-27 |
K193336 |
Synedgen, Inc.
|
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse |