OLRUnclassified

Oral Wound Dressing

Unknown

OLR is the FDA product code for Oral Wound Dressing. FDA's definition for this code reads: "Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ". As of 2026-09-10, FDA records hold 43 510(k) clearances under this code, the most recent dated 2026-08-05, and one recall.

Classification record

Product code: OLR
Device name: Oral Wound Dressing
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.
Device class: Unclassified
Review panel: Unknown
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 43
Ingested recalls: 1

Clearances, product code OLR

By decision year

43 clearances under product code OLR with a decision year between 1994 and 2026, 2026 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code OLR by decision year
Year	Clearances
1994	1
1995	1
1997	1
1998	1
2001	2
2002	1
2003	1
2004	2
2005	1
2006	3
2007	3
2008	2
2009	2
2011	3
2012	1
2014	1
2018	1
2019	2
2020	2
2021	2
2022	2
2023	1
2025	3
2026	4

Applicants with the most clearances

Product code OLR

Applicants holding the most 510(k) clearances under product code OLR
Applicant	Clearances
Carrington Laboratories, Inc.	5
Sinclair Pharmaceuticals Ltd	4
Forward Science, LLC	2
MPM Medical	2
Sa3, LLC	2
Tbm Corporation	2
3-D Matrix, Inc.	1
Access Pharmaceuticals, Inc.	1
Aeon Astron Europe B.V.	1
Belcher Pharmaceuticals, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order