# OLR · Oral Wound Dressing

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/DE-misc/OLR

## Overview

- **Product Code:** OLR
- **Device Name:** Oral Wound Dressing
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.  Unclassified status per SE to MGQ.

## Recent Cleared Devices (20 of 39)

Showing 20 most recent of 39 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253758](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K253758.md) | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) | Dec 18, 2025 | SESE |
| [K252425](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K252425.md) | Silatrix Oral Gel | Sa3, LLC | Oct 23, 2025 | SESE |
| [K241283](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K241283.md) | Elemental Granulate | Zinkh NV | Jan 3, 2025 | SESE |
| [K230529](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K230529.md) | HealiAid Dental Collagen Wound Dressing | Maxigen Biotech, Inc. | Nov 22, 2023 | SESE |
| [K221428](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K221428.md) | PerioStom Dental Dressing | Forward Science, LLC | Dec 22, 2022 | SESE |
| [K211851](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K211851.md) | Ora-Aid | Tbm Corporation | Jan 11, 2022 | SESE |
| [K210211](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K210211.md) | PuraStat-OM | 3-D Matrix, Inc. | Oct 8, 2021 | SESE |
| [K203091](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K203091.md) | MucoLock Oral Gel | Pcca, Inc. | Feb 12, 2021 | SESE |
| [K202000](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K202000.md) | Silatrix Oral Gel | Sa3, LLC | Nov 20, 2020 | SESE |
| [K193336](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K193336.md) | Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse | Synedgen, Inc. | May 27, 2020 | SESE |
| [K191987](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K191987.md) | Orapeutic | Forward Science | Nov 27, 2019 | SESE |
| [K183436](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K183436.md) | OraCure | Tbm Corporation | Sep 18, 2019 | SESE |
| [K173196](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K173196.md) | SUNTOUCH Dental Dressing | Huizhou Foryou Medical Devices Co., Ltd. | Jan 24, 2018 | SESE |
| [K130959](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K130959.md) | AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL | Bioplax Limited | Apr 4, 2014 | SESE |
| [K112568](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K112568.md) | AONGEN DENTAL COLLAGEN MATRIX | Aeon Astron Europe B.V. | Mar 1, 2012 | SESE |
| [K101769](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K101769.md) | EPISIL | Camurus AB | Sep 13, 2011 | SESE |
| [K110750](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K110750.md) | PERIOPATCH | Mis Implants Technologies , Ltd. | Apr 28, 2011 | SESE |
| [K103054](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K103054.md) | PERIOPATCH | Izun Pharmaceuticals Corporation | Feb 7, 2011 | SESE |
| [K090612](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K090612.md) | BENACEL | Unicare Biomedical | Jul 24, 2009 | SESE |
| [K081372](https://fda.innolitics.com/submissions/DE/DE-misc/OLR/K081372.md) | GELX ORAL GEL | Bmg Pharma, LLC | Feb 4, 2009 | SESE |

## Top Applicants

- Carrington Laboratories, Inc. — 5 clearances
- Sinclair Pharmaceuticals, Ltd. — 4 clearances
- Mpm Medical., Inc. — 2 clearances
- Sa3, LLC — 2 clearances
- Tbm Corporation — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/DE/DE-misc/OLR](https://fda.innolitics.com/submissions/DE/DE-misc/OLR)

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