K183436 is an FDA 510(k) clearance for the OraCure. This device is classified as a Oral Wound Dressing.
Submitted by Tbm Corporation (Gwangju, KR). The FDA issued a Cleared decision on September 18, 2019, 281 days after receiving the submission on December 11, 2018.
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 | K183436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2018 |
| Decision Date | September 18, 2019 |
| Days to Decision | 281 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. |