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 Sa3, LLC, Medizin Produkte Neustadt GmbH (Mpn) and Zinkh NV.
FDA 510(k) Cleared Oral Wound Dressing Devices (Product Code OLR)
About Product Code OLR - Regulatory Context
510(k) Submission Activity
39 total 510(k) submissions under product code OLR since 1994, with 39 receiving FDA clearance (average review time: 154 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OLR have taken an average of 116 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 →