K203091 is an FDA 510(k) clearance for the MucoLock Oral Gel. This device is classified as a Oral Wound Dressing.
Submitted by Pcca, Inc. (Houston, US). The FDA issued a Cleared decision on February 12, 2021, 122 days after receiving the submission on October 13, 2020.
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 | K203091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2020 |
| Decision Date | February 12, 2021 |
| Days to Decision | 122 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. |