OLR — Oral Wound Dressing Class U
Classification Details
- Product Code
- OLR
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Unknown
- Implant
- No
Definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253758 | medizin produkte neustadt gmbh (mpn) | Dental Cone; Dental Sponge | December 18, 2025 |
| K252425 | sa3 | Silatrix Oral Gel | October 23, 2025 |
| K241283 | zinkh | Elemental Granulate | January 3, 2025 |
| K230529 | maxigen biotech | HealiAid Dental Collagen Wound Dressing | November 22, 2023 |
| K221428 | forward science | PerioStom Dental Dressing | December 22, 2022 |
| K211851 | tbm corporation | Ora-Aid | January 11, 2022 |
| K210211 | 3-d matrix | PuraStat-OM | October 8, 2021 |
| K203091 | pcca | MucoLock Oral Gel | February 12, 2021 |
| K202000 | sa3 | Silatrix Oral Gel | November 20, 2020 |
| K193336 | synedgen | Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse | May 27, 2020 |
| K191987 | forward science | Orapeutic | November 27, 2019 |
| K183436 | tbm corporation | OraCure | September 18, 2019 |
| K173196 | huizhou foryou medical devices co | SUNTOUCH Dental Dressing | January 24, 2018 |
| K130959 | bioplax limited | AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GE | April 4, 2014 |
| K112568 | aeon astron europe | AONGEN DENTAL COLLAGEN MATRIX | March 1, 2012 |
| K101769 | camurus | EPISIL | September 13, 2011 |
| K110750 | mis implants technologies | PERIOPATCH | April 28, 2011 |
| K103054 | izun pharmaceuticals corporation | PERIOPATCH | February 7, 2011 |
| K090612 | unicare biomedical | BENACEL | July 24, 2009 |
| K081372 | bmg pharma | GELX ORAL GEL | February 4, 2009 |