Product Code: OLR FDA unclassified

Oral Wound Dressing

Unknown

The Oral Wound Dressing (product code OLR) is an unclassified device reviewed by the Dental (DE) panel that cleared 510(k) review but remains without formal classification, with unclassified status established via a substantial equivalence determination. It is intended to function as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. The device is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OLR
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 41 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260126	Curajel Oral Gel	Jun 15, 2026	Substantially Equivalent	USpharma, Ltd.
K253816	MuCover (proposed name) Oral Wound Dressing	May 21, 2026	Substantially Equivalent	MoleculeX Co., Ltd.
K253758	Dental Cone; Dental Sponge	Dec 18, 2025	Substantially Equivalent	Medizin Produkte Neustadt GmbH (Mpn)
K252425	Silatrix Oral Gel	Oct 23, 2025	Substantially Equivalent	Sa3, LLC
K241283	Elemental Granulate	Jan 03, 2025	Substantially Equivalent	Zinkh NV
K230529	HealiAid Dental Collagen Wound Dressing	Nov 22, 2023	Substantially Equivalent	Maxigen Biotech, Inc.
K221428	PerioStom Dental Dressing	Dec 22, 2022	Substantially Equivalent	Forward Science, LLC
K211851	Ora-Aid	Jan 11, 2022	Substantially Equivalent	Tbm Corporation
K210211	PuraStat-OM	Oct 08, 2021	Substantially Equivalent	3-D Matrix, Inc.
K203091	MucoLock Oral Gel	Feb 12, 2021	Substantially Equivalent	Pcca, Inc.
K202000	Silatrix Oral Gel	Nov 20, 2020	Substantially Equivalent	Sa3, LLC
K193336	Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse	May 27, 2020	Substantially Equivalent	Synedgen, Inc.
K191987	Orapeutic	Nov 27, 2019	Substantially Equivalent	Forward Science
K183436	OraCure	Sep 18, 2019	Substantially Equivalent	Tbm Corporation
K173196	SUNTOUCH Dental Dressing	Jan 24, 2018	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.
K130959	AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL	Apr 04, 2014	Substantially Equivalent	Bioplax Limited
K112568	AONGEN DENTAL COLLAGEN MATRIX	Mar 01, 2012	Substantially Equivalent	Aeon Astron Europe B.V.
K101769	EPISIL	Sep 13, 2011	Substantially Equivalent	Camurus AB
K110750	PERIOPATCH	Apr 28, 2011	Substantially Equivalent	Mis Implants Technologies , Ltd.
K103054	PERIOPATCH	Feb 07, 2011	Substantially Equivalent	Izun Pharmaceuticals Corporation
K090612	BENACEL	Jul 24, 2009	Substantially Equivalent	Unicare Biomedical
K081372	GELX ORAL GEL	Feb 04, 2009	Substantially Equivalent	Bmg Pharma, LLC
K082553	REXASTOM ORAL EASE	Nov 21, 2008	Substantially Equivalent	Rexaderm, Inc.
K082856	CARAPASTE ORAL WOUND DRESSING	Oct 15, 2008	Substantially Equivalent	Mcgrath Pharmaceuticals, Inc.
K070842	ULCELOOCIN ORAL ULCER PATCH	Jun 07, 2007	Substantially Equivalent	Sunshine International Group, Inc.
K053342	GENGIGEL MOUTHRINSE	Mar 13, 2007	Substantially Equivalent	Ricerfarma Srl
K063148	SOCK IT! ORAL PAIN GEL	Jan 17, 2007	Substantially Equivalent	Merlin Group Dba Mcmerlin Dental Company
K062795	MUGARD MUCOADHESIVE ORAL WOUND RINSE	Dec 11, 2006	Substantially Equivalent	Access Pharmaceuticals, Inc.
K060363	HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12	Jul 07, 2006	Substantially Equivalent	Hemcon, Inc.
K060340	ORAMAGIC PLUS ORAL WOUND RINSE	May 10, 2006	Substantially Equivalent	Mpm Medical., Inc.
K042722	ALOCLAIR ORAL SPRAY	Jan 13, 2005	Substantially Equivalent	Sinclair Pharmaceuticals, Ltd.
K042400	MUCOTROL CONCENTRATED ORAL GEL WAFER	Nov 24, 2004	Substantially Equivalent	Belcher Pharmaceuticals, Inc.
K040950	ALOCLAIR ORAL GEL	Jun 21, 2004	Substantially Equivalent	Sinclair Pharmaceuticals, Ltd.
K024180	ORAMAGICRX ORAL WOUND RINSE	Mar 14, 2003	Substantially Equivalent	Mpm Medical., Inc.
K023155	ALOCLAIR ORAL RINSE	Nov 25, 2002	Substantially Equivalent	Sinclair Pharmaceuticals, Ltd.
K013056	GELCLAIR CONCENTRATED ORAL GEL	Dec 21, 2001	Substantially Equivalent	Sinclair Pharmaceuticals, Ltd.
K012126	THE SALICEPT ORAL PATCH	Oct 03, 2001	Substantially Equivalent	Carrington Laboratories, Inc.
K983182	ALOE THERAPY ORAL RINSE	Dec 10, 1998	Substantially Equivalent	Carrington Laboratories, Inc.
K964852	RADIACARE ORAL WOUND RINSE	Mar 03, 1997	Substantially Equivalent	Carrington Laboratories, Inc.
K953423	CASRRASYN ORAL WOUND DRESSING	Oct 11, 1995	Substantially Equivalent	Carrington Laboratories, Inc.
K933741	CARRASYN ORAL WOUND DRESSING	May 04, 1994	Substantially Equivalent for Some Indications	Carrington Laboratories, Inc.