Cleared Special

K253758 - Dental Cone (FDA 510(k) Clearance)

Also includes:
Dental Sponge
K253758 · Medizin Produkte Neustadt GmbH (Mpn) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
23d
Days
-
Risk

K253758 is an FDA 510(k) clearance for the Dental Cone. Classified as Oral Wound Dressing (product code OLR).

Submitted by Medizin Produkte Neustadt GmbH (Mpn) (Saal/Donau Bavaria, DE). The FDA issued a Cleared decision on December 18, 2025 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medizin Produkte Neustadt GmbH (Mpn) devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - OLR Oral Wound Dressing

All 38
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K253758.
Silatrix Oral Gel
K252425 · Sa3, LLC · Oct 2025
Elemental Granulate
K241283 · Zinkh NV · Jan 2025
HealiAid Dental Collagen Wound Dressing
K230529 · Maxigen Biotech, Inc. · Nov 2023
PerioStom Dental Dressing
K221428 · Forward Science, LLC · Dec 2022
Ora-Aid
K211851 · Tbm Corporation · Jan 2022
PuraStat-OM
K210211 · 3-D Matrix, Inc. · Oct 2021