Dental Cone; Dental Sponge— 510(k) K253758
Substantially EquivalentMedizin Produkte Neustadt GmbH (Mpn)
FDA 510(k) clearance K253758 for Dental Cone; Dental Sponge, Substantially Equivalent on 2025-12-18. Applicant: Medizin Produkte Neustadt GmbH (Mpn).
Clearance details
- Applicant
- Medizin Produkte Neustadt GmbH (Mpn)
- Product code
- Code OLR
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Saal/Donau Bavaria, DE
Adverse events under product code OLR
product code OLR- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.