FDA product code OLR: Oral Wound Dressing
OLR is the FDA product code for oral wound dressing. It is a Unclassified device, reviewed by the Dental panel. FDA has cleared 43 510(k) submissions under OLR, 10 in the last five years, from 33 different applicants. The average 510(k) review took 161 days (median 122); 174 days on average over the last three years. FDA has posted 1 recall for OLR devices, 1 initiated in the last five years.
Definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
Classification
| Field | Value |
|---|---|
| Device name | Oral Wound Dressing |
| Device class | Unclassified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for OLR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 114 |
| 2019 | 2 | 203 |
| 2020 | 2 | 150 |
| 2021 | 2 | 188 |
| 2022 | 2 | 215 |
| 2023 | 1 | 268 |
| 2025 | 3 | 116 |
| 2026 | 4 | 233 |
Compare with all 510(k) review times · Search every OLR clearance
Top OLR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carrington Laboratories, Inc. | 5 | 2001-10-03 |
| Sinclair Pharmaceuticals, Ltd. | 4 | 2005-01-13 |
| Sa3, LLC | 2 | 2025-10-23 |
| Tbm Corporation | 2 | 2022-01-11 |
| Mpm Medical., Inc. | 2 | 2006-05-10 |
28 more applicants have OLR clearances. See the full list in Caduvo.
Most recent OLR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260120 | HCS Innovation, LLC | NaturaJel Oral Wound Care Kit | 2026-08-05 | 202 |
| K251908 | Emanate Biomedical | Emanate Tray | 2026-07-29 | 404 |
| K260126 | USpharma, Ltd. | Curajel Oral Gel | 2026-06-15 | 151 |
| K253816 | MoleculeX Co., Ltd. | MuCover (proposed name) Oral Wound Dressing | 2026-05-21 | 174 |
| K253758 | Medizin Produkte Neustadt GmbH (Mpn) | Dental Cone; Dental Sponge | 2025-12-18 | 23 |
Recalls for OLR devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-02-21.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code OLR?
OLR is the FDA product code for oral wound dressing. It is a Unclassified device, reviewed by the Dental panel.
What device class is OLR?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLR?
Across 43 cleared submissions the average was 161 days from receipt to decision (median 122).
Which companies have the most OLR clearances?
Carrington Laboratories, Inc. (5); Sinclair Pharmaceuticals, Ltd. (4); Sa3, LLC (2); Tbm Corporation (2); Mpm Medical., Inc. (2).
Have OLR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-02-21.
Next steps
- Run an FDA pathway report with predicate devices for product code OLR
- Run a recall and safety report across every OLR manufacturer
- Watch product code OLR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times