OLSUnclassified

Oral Wound Dressing W/Drug And/Or Biologic

Unknown

OLS is the FDA product code for Oral Wound Dressing W/Drug And/Or Biologic. 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 no 510(k) clearances under this code and no recalls.

Classification record

Product code: OLS
Device name: Oral Wound Dressing W/Drug And/Or Biologic
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: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OLS.

Recent clearances

Product code OLS

FDA records hold no clearances under product code OLS.

Recent recalls

Product code OLS

FDA records show no recalls under product code OLS.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)