← FDA Medical Device Classifications
Oral Wound Dressing
OLR · Unclassified · Unknown
Classification
- FDA Product Code
OLR- Device class
- Unclassified
- Regulation
- —
- Review panel
- DE
- Medical specialty
- Unknown
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
Market data
- Cleared 510(k) submissions
- 39
- Registered establishments
- 29
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown