FDA product code OLR
Oral Wound Dressing
Unknown·Class U·21 CFR
US regulatory classifications
- US Product Code (FDA)
- OLRView Product Code Classification →
- US Risk Class (FDA)
- Class U
- US Regulation (CFR)
- 21 CFRView CFR Regulation →
- Medical specialty
- Unknown
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
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About this record
Oral Wound Dressing is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.