Submission Details
| 510(k) Number | K253758 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Dental Cone; Dental Sponge
Dec 2025
Decision
23d
Days
—
Risk
About This 510(k) Submission
K253758 is an FDA 510(k) clearance for the Dental Cone; Dental Sponge, 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 review panel.
Device Classification
| 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. |
Manufacturer
Medizin Produkte Neustadt GmbH (Mpn)
Saal/Donau Bavaria · DE
Danielle Lindner
1 submissions
1 cleared
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