Product code OLR · Class U
Oral Wound Dressing
5510(k)s in 12 months (43 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OLR
| Company | 510(k)s | Recalls |
|---|---|---|
| Carrington Laboratories, Inc. | 5 | 0 |
| Sinclair Pharmaceuticals, Ltd. | 4 | 0 |
| Sa3, LLC | 2 | 1 |
| Forward Science | 2 | 0 |
| Mpm Medical., Inc. | 2 | 0 |
| Tbm Corporation | 2 | 0 |
| 3-D Matrix, Inc. | 1 | 0 |
| Access Pharmaceuticals, Inc. | 1 | 0 |
| Aeon Astron Europe B.V. | 1 | 0 |
| Belcher Pharmaceuticals, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 2026 | K260120 | NaturaJel Oral Wound Care Kit HCS Innovation, LLC | OLR |
| Jul 29, 2026 | K251908 | Emanate Tray Emanate Biomedical | OLR |
| Jun 15, 2026 | K260126 | Curajel Oral Gel USpharma, Ltd. | OLR |
| May 21, 2026 | K253816 | MuCover (proposed name) Oral Wound Dressing MoleculeX Co., Ltd., TW | OLR |
| Dec 18, 2025 | K253758 | Dental Cone; Dental Sponge Medizin Produkte Neustadt GmbH (Mpn), DE | OLR |
| Oct 23, 2025 | K252425 | Silatrix Oral Gel Sa3, LLC | OLR |
| Jan 3, 2025 | K241283 | Elemental Granulate Zinkh NV, BE | OLR |
| Nov 22, 2023 | K230529 | HealiAid Dental Collagen Wound Dressing Maxigen Biotech, Inc., TW | OLR |
| Dec 22, 2022 | K221428 | PerioStom Dental Dressing Forward Science, LLC | OLR |
| Jan 11, 2022 | K211851 | Ora-Aid Tbm Corporation, KR | OLR |
| Oct 8, 2021 | K210211 | PuraStat-OM 3-D Matrix, Inc. | OLR |
| Feb 12, 2021 | K203091 | MucoLock Oral Gel Pcca, Inc. | OLR |
| Nov 20, 2020 | K202000 | Silatrix Oral Gel Sa3, LLC | OLR |
| May 27, 2020 | K193336 | Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse Synedgen, Inc. | OLR |
| Nov 27, 2019 | K191987 | Orapeutic Forward Science | OLR |
| Sep 18, 2019 | K183436 | OraCure Tbm Corporation, KR | OLR |
| Jan 24, 2018 | K173196 | SUNTOUCH Dental Dressing Huizhou Foryou Medical Devices Co., Ltd., CN | OLR |
| Apr 4, 2014 | K130959 | AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL Bioplax Limited | OLR |
| Mar 1, 2012 | K112568 | AONGEN DENTAL COLLAGEN MATRIX Aeon Astron Europe B.V., NL | OLR |
| Sep 13, 2011 | K101769 | EPISIL Camurus AB | OLR |
| Apr 28, 2011 | K110750 | PERIOPATCH Mis Implants Technologies , Ltd., IL | OLR |
| Feb 7, 2011 | K103054 | PERIOPATCH Izun Pharmaceuticals Corporation | OLR |
| Jul 24, 2009 | K090612 | BENACEL Unicare Biomedical | OLR |
| Feb 4, 2009 | K081372 | GELX ORAL GEL Bmg Pharma, LLC | OLR |
| Nov 21, 2008 | K082553 | REXASTOM ORAL EASE Rexaderm, Inc. | OLR |
| Oct 15, 2008 | K082856 | CARAPASTE ORAL WOUND DRESSING Mcgrath Pharmaceuticals, Inc. | OLR |
| Jun 7, 2007 | K070842 | ULCELOOCIN ORAL ULCER PATCH Sunshine International Group, Inc. | OLR |
| Mar 13, 2007 | K053342 | GENGIGEL MOUTHRINSE Ricerfarma Srl | OLR |
| Jan 17, 2007 | K063148 | SOCK IT! ORAL PAIN GEL Merlin Group Dba Mcmerlin Dental Company | OLR |
| Dec 11, 2006 | K062795 | MUGARD MUCOADHESIVE ORAL WOUND RINSE Access Pharmaceuticals, Inc. | OLR |
| Jul 7, 2006 | K060363 | HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12 Hemcon, Inc. | OLR |
| May 10, 2006 | K060340 | ORAMAGIC PLUS ORAL WOUND RINSE Mpm Medical., Inc. | OLR |
| Jan 13, 2005 | K042722 | ALOCLAIR ORAL SPRAY Sinclair Pharmaceuticals, Ltd., GB | OLR |
| Nov 24, 2004 | K042400 | MUCOTROL CONCENTRATED ORAL GEL WAFER Belcher Pharmaceuticals, Inc. | OLR |
| Jun 21, 2004 | K040950 | ALOCLAIR ORAL GEL Sinclair Pharmaceuticals, Ltd. | OLR |
| Mar 14, 2003 | K024180 | ORAMAGICRX ORAL WOUND RINSE Mpm Medical., Inc. | OLR |
| Nov 25, 2002 | K023155 | ALOCLAIR ORAL RINSE Sinclair Pharmaceuticals, Ltd., GB | OLR |
| Dec 21, 2001 | K013056 | GELCLAIR CONCENTRATED ORAL GEL Sinclair Pharmaceuticals, Ltd., GB | OLR |
| Oct 3, 2001 | K012126 | THE SALICEPT ORAL PATCH Carrington Laboratories, Inc. | OLR |
| Dec 10, 1998 | K983182 | ALOE THERAPY ORAL RINSE Carrington Laboratories, Inc. | OLR |
| Mar 3, 1997 | K964852 | RADIACARE ORAL WOUND RINSE Carrington Laboratories, Inc. | OLR |
| Oct 11, 1995 | K953423 | CASRRASYN ORAL WOUND DRESSING Carrington Laboratories, Inc. | OLR |
| May 4, 1994 | K933741 | CARRASYN ORAL WOUND DRESSING Carrington Laboratories, Inc. | OLR |
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