K191987 is an FDA 510(k) clearance for the Orapeutic. This device is classified as a Oral Wound Dressing.
Submitted by Forward Science (Stafford, US). The FDA issued a Cleared decision on November 27, 2019, 125 days after receiving the submission on July 25, 2019.
This device falls under the General & Plastic Surgery 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 | K191987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2019 |
| Decision Date | November 27, 2019 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| 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. |