K230529 is an FDA 510(k) clearance for the HealiAid Dental Collagen Wound Dressing. This device is classified as a Oral Wound Dressing.
Submitted by Maxigen Biotech, Inc. (Taoyuan, TW). The FDA issued a Cleared decision on November 22, 2023, 268 days after receiving the submission on February 27, 2023.
This device falls under the Dental FDA review panel. Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq..
| 510(k) Number | K230529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2023 |
| Decision Date | November 22, 2023 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | OLR - Oral Wound Dressing |
| Device Class | - |
| Definition | Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq. |