K253758 is an FDA 510(k) clearance for the Dental Cone. This device is classified as a Oral Wound Dressing.
Submitted by Medizin Produkte Neustadt GmbH (Mpn) (Saal/Donau Bavaria, DE). The FDA issued a Cleared decision on December 18, 2025, 23 days after receiving the submission on November 25, 2025.
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 | K253758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2025 |
| Decision Date | December 18, 2025 |
| Days to Decision | 23 days |
| Submission Type | Special |
| 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. |