510(k) K230529
K230529 is an FDA 510(k) premarket notification submitted by Maxigen Biotech, Inc. for the device "HealiAid Dental Collagen Wound Dressing". The FDA issued a decision of Substantially Equivalent on November 22, 2023. The device falls under product code OLR (Oral Wound Dressing), a Class U device. Maxigen Biotech, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2023
- Date Received
- February 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oral Wound Dressing
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.