K253758
- 510(k) number
- K253758
- Device name
- Dental Cone; Dental Sponge
- Applicant
- Medizin Produkte Neustadt GmbH (Mpn) DE
- Product code
- OLR — Oral Wound Dressing
- Decision date
- 2025-12-18
- Date received
- 2025-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253758.pdf
Official FDA record: K253758
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.