FDA 510(k)
FDA unclassified
Substantially Equivalent
🇩🇪 Germany
Dental Cone; Dental Sponge
K Number: K253758
·
Decision Dec 18, 2025
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
40
Applicant Total
1
Review Days
23
Basic Information
- Device Name
- Dental Cone; Dental Sponge
- K Number
- K253758
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medizin Produkte Neustadt GmbH (Mpn)
- Date Received
- November 25, 2025
- Decision Date
- December 18, 2025
- Product Code
- OLR
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLR | Oral Wound Dressing | FDA unclassified | Unknown |
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