FDA product code OLS: Oral Wound Dressing W/Drug And/Or Biologic
OLS is the FDA product code for oral wound dressing w/drug and/or biologic. It is a Unclassified device, reviewed by the Dental panel. Devices under OLS reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per se to mgq.
Classification
| Field | Value |
|---|---|
| Device name | Oral Wound Dressing W/Drug And/Or Biologic |
| Device class | Unclassified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Recalls for OLS devices
openFDA lists no recalls for product code OLS.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J8499 — Prescription drug, oral, non chemotherapeutic, nos
Frequently asked questions
What is FDA product code OLS?
OLS is the FDA product code for oral wound dressing w/drug and/or biologic. It is a Unclassified device, reviewed by the Dental panel.
What device class is OLS?
Unclassified. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OLS
- Run a recall and safety report across every OLS manufacturer
- Watch product code OLS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times