OLR

FDA Product Code OLR: Oral Wound Dressing

Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Leading manufacturers include Tbm Corporation, Sa3, LLC and Carrington Laboratories, Inc..

43
Total
43
Cleared
161d
Avg days
1994
Since
Growing category - 7 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 183d recently vs 157d historically

FDA 510(k) Cleared Oral Wound Dressing Devices (Product Code OLR)

43 devices
1–24 of 43
Cleared Aug 05, 2026
NaturaJel™ Oral Wound Care Kit
K260120
HCS Innovation, LLC
Dental · 202d
Cleared Jul 29, 2026
Emanate Tray
K251908
Emanate Biomedical
Dental · 404d
Cleared Jun 15, 2026
Curajel™ Oral Gel
K260126
USpharma, Ltd.
Dental · 151d
Cleared May 21, 2026
MuCover (proposed name) Oral Wound Dressing
K253816
MoleculeX Co., Ltd.
Dental · 174d
Cleared Dec 18, 2025
Dental Cone
K253758
Medizin Produkte Neustadt GmbH (Mpn)
Dental · 23d
Cleared Oct 23, 2025
Silatrix Oral Gel
K252425
Sa3, LLC
Dental · 83d
Cleared Jan 03, 2025
Elemental Granulate
K241283
Zinkh NV
Dental · 241d
Cleared Nov 22, 2023
HealiAid Dental Collagen Wound Dressing
K230529
Maxigen Biotech, Inc.
Dental · 268d
Cleared Dec 22, 2022
PerioStom Dental Dressing
K221428
Forward Science, LLC
General & Plastic Surgery · 220d
Cleared Jan 11, 2022
Ora-Aid
K211851
Tbm Corporation
General & Plastic Surgery · 210d
Cleared Oct 08, 2021
PuraStat-OM
K210211
3-D Matrix, Inc.
General & Plastic Surgery · 254d
Cleared Feb 12, 2021
MucoLock Oral Gel
K203091
Pcca, Inc.
Dental · 122d
Cleared Nov 20, 2020
Silatrix Oral Gel
K202000
Sa3, LLC
General & Plastic Surgery · 123d
Cleared May 27, 2020
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
K193336
Synedgen, Inc.
General & Plastic Surgery · 177d
Cleared Nov 27, 2019
Orapeutic
K191987
Forward Science
General & Plastic Surgery · 125d
Cleared Sep 18, 2019
OraCure
K183436
Tbm Corporation
Dental · 281d
Cleared Jan 24, 2018
SUNTOUCH Dental Dressing
K173196
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 114d
Cleared Apr 04, 2014
AFTAMED MOUTHWASH
K130959
Bioplax Limited
General & Plastic Surgery · 364d
Cleared Mar 01, 2012
AONGEN DENTAL COLLAGEN MATRIX
K112568
Aeon Astron Europe B.V.
General & Plastic Surgery · 177d
Cleared Sep 13, 2011
EPISIL
K101769
Camurus AB
General & Plastic Surgery · 446d
Cleared Apr 28, 2011
PERIOPATCH
K110750
Mis Implants Technologies , Ltd.
General & Plastic Surgery · 42d
Cleared Jul 24, 2009
BENACEL
K090612
Unicare Biomedical
General & Plastic Surgery · 140d
Cleared Feb 04, 2009
GELX ORAL GEL
K081372
Bmg Pharma, LLC
General & Plastic Surgery · 264d
Cleared Nov 21, 2008
REXASTOM ORAL EASE
K082553
Rexaderm, Inc.
General & Plastic Surgery · 79d

About Product Code OLR - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code OLR since 1994, with 43 receiving FDA clearance (average review time: 161 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OLR Product Code

Recent submissions under OLR have taken an average of 183 days to reach a decision - up from 157 days historically. Manufacturers should account for longer review timelines in current project planning.

OLR devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →