Atlas FDA

OLR

43 FDA 510(k) clearances · Product code

122 daysmedian time to decision
281 days90th percentile
43clearances measured

FDA profile

Official device name
Oral Wound Dressing
Device class
Unclassified
Medical specialty
Unknown
FDA definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
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RecordFirmDate
NaturaJel™ Oral Wound Care Kit (K260120)HCS Innovation, LLC2026-08-05
Emanate Tray (K251908)Emanate Biomedical2026-07-29
Curajel™ Oral Gel (K260126)USpharma, Ltd.2026-06-15
MuCover (proposed name) Oral Wound Dressing (K253816)MoleculeX Co., Ltd.2026-05-21
Dental Cone; Dental Sponge (K253758)Medizin Produkte Neustadt GmbH (Mpn)2025-12-18
Silatrix Oral Gel (K252425)Sa3, LLC2025-10-23
Elemental Granulate (K241283)Zinkh NV2025-01-03
HealiAid Dental Collagen Wound Dressing (K230529)Maxigen Biotech, Inc.2023-11-22
PerioStom Dental Dressing (K221428)Forward Science, LLC2022-12-22
Ora-Aid (K211851)Tbm Corporation2022-01-11
PuraStat-OM (K210211)3-D Matrix, Inc.2021-10-08
MucoLock Oral Gel (K203091)Pcca, Inc.2021-02-12
Silatrix Oral Gel (K202000)Sa3, LLC2020-11-20
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse (K193336)Synedgen, Inc.2020-05-27
Orapeutic (K191987)Forward Science2019-11-27
OraCure (K183436)Tbm Corporation2019-09-18
SUNTOUCH Dental Dressing (K173196)Huizhou Foryou Medical Devices Co., Ltd.2018-01-24
AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL (K130959)Bioplax Limited2014-04-04
AONGEN DENTAL COLLAGEN MATRIX (K112568)Aeon Astron Europe B.V.2012-03-01
EPISIL (K101769)Camurus AB2011-09-13
PERIOPATCH (K110750)Mis Implants Technologies , Ltd.2011-04-28
PERIOPATCH (K103054)Izun Pharmaceuticals Corporation2011-02-07
BENACEL (K090612)Unicare Biomedical2009-07-24
GELX ORAL GEL (K081372)Bmg Pharma, LLC2009-02-04
REXASTOM ORAL EASE (K082553)Rexaderm, Inc.2008-11-21
CARAPASTE ORAL WOUND DRESSING (K082856)Mcgrath Pharmaceuticals, Inc.2008-10-15
ULCELOOCIN ORAL ULCER PATCH (K070842)Sunshine International Group, Inc.2007-06-07
GENGIGEL MOUTHRINSE (K053342)Ricerfarma Srl2007-03-13
SOCK IT! ORAL PAIN GEL (K063148)Merlin Group Dba Mcmerlin Dental Company2007-01-17
MUGARD MUCOADHESIVE ORAL WOUND RINSE (K062795)Access Pharmaceuticals, Inc.2006-12-11
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12 (K060363)Hemcon, Inc.2006-07-07
ORAMAGIC PLUS ORAL WOUND RINSE (K060340)Mpm Medical., Inc.2006-05-10
ALOCLAIR ORAL SPRAY (K042722)Sinclair Pharmaceuticals, Ltd.2005-01-13
MUCOTROL CONCENTRATED ORAL GEL WAFER (K042400)Belcher Pharmaceuticals, Inc.2004-11-24
ALOCLAIR ORAL GEL (K040950)Sinclair Pharmaceuticals, Ltd.2004-06-21
ORAMAGICRX ORAL WOUND RINSE (K024180)Mpm Medical., Inc.2003-03-14
ALOCLAIR ORAL RINSE (K023155)Sinclair Pharmaceuticals, Ltd.2002-11-25
GELCLAIR CONCENTRATED ORAL GEL (K013056)Sinclair Pharmaceuticals, Ltd.2001-12-21
THE SALICEPT ORAL PATCH (K012126)Carrington Laboratories, Inc.2001-10-03
ALOE THERAPY ORAL RINSE (K983182)Carrington Laboratories, Inc.1998-12-10
RADIACARE ORAL WOUND RINSE (K964852)Carrington Laboratories, Inc.1997-03-03
CASRRASYN ORAL WOUND DRESSING (K953423)Carrington Laboratories, Inc.1995-10-11
CARRASYN ORAL WOUND DRESSING (K933741)Carrington Laboratories, Inc.1994-05-04

Track OLR automatically

Every clearance here is in the API, with alerts when new ones post.