OLR · Oral Wound Dressing

· Class U

Overview

Product CodeOLR
Device NameOral Wound Dressing
Device ClassClass U
Review Panel

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.

RecordDevice NameApplicantDecision DateDecision
K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)Dec 18, 2025SESE
K252425Silatrix Oral GelSa3, LLCOct 23, 2025SESE
K241283Elemental GranulateZinkh NVJan 3, 2025SESE
K230529HealiAid Dental Collagen Wound DressingMaxigen Biotech, Inc.Nov 22, 2023SESE
K221428PerioStom Dental DressingForward Science, LLCDec 22, 2022SESE
K211851Ora-AidTbm CorporationJan 11, 2022SESE
K210211PuraStat-OM3-D Matrix, Inc.Oct 8, 2021SESE
K203091MucoLock Oral GelPcca, Inc.Feb 12, 2021SESE
K202000Silatrix Oral GelSa3, LLCNov 20, 2020SESE
K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseSynedgen, Inc.May 27, 2020SESE
K191987OrapeuticForward ScienceNov 27, 2019SESE
K183436OraCureTbm CorporationSep 18, 2019SESE
K173196SUNTOUCH Dental DressingHuizhou Foryou Medical Devices Co., Ltd.Jan 24, 2018SESE
K130959AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GELBioplax LimitedApr 4, 2014SESE
K112568AONGEN DENTAL COLLAGEN MATRIXAeon Astron Europe B.V.Mar 1, 2012SESE
K101769EPISILCamurus ABSep 13, 2011SESE
K110750PERIOPATCHMis Implants Technologies , Ltd.Apr 28, 2011SESE
K103054PERIOPATCHIzun Pharmaceuticals CorporationFeb 7, 2011SESE
K090612BENACELUnicare BiomedicalJul 24, 2009SESE
K081372GELX ORAL GELBmg Pharma, LLCFeb 4, 2009SESE

Top Applicants

Innolitics

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