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 Maxigen Biotech, Inc..

40
Total
40
Cleared
154d
Avg days
1994
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 130d recently vs 157d historically

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

40 devices
1–24 of 40
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

About Product Code OLR - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code OLR since 1994, with 40 receiving FDA clearance (average review time: 154 days).

Submission volume has increased in recent years - 4 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 130 days to reach a decision - down from 157 days historically, suggesting improved FDA processing for this classification.

OLR devices are reviewed by the Dental panel. Browse all Dental devices →