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510(k) K253758

Dental Cone; Dental Sponge by Medizin Produkte Neustadt GmbH (Mpn) — Product Code OLR

K253758 is an FDA 510(k) premarket notification submitted by Medizin Produkte Neustadt GmbH (Mpn) for the device "Dental Cone; Dental Sponge". The FDA issued a decision of Substantially Equivalent on December 18, 2025. The device falls under product code OLR (Oral Wound Dressing), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2025
Date Received
November 25, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oral Wound Dressing
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Other clearances for product code OLR

  • K260126 — Curajel™ Oral Gel (June 15, 2026)
  • K253816 — MuCover (proposed name) Oral Wound Dressing (May 21, 2026)
  • K252425 — Silatrix Oral Gel (October 23, 2025)
  • K241283 — Elemental Granulate (January 3, 2025)
  • K230529 — HealiAid Dental Collagen Wound Dressing (November 22, 2023)
  • K221428 — PerioStom Dental Dressing (December 22, 2022)
  • K211851 — Ora-Aid (January 11, 2022)
  • K210211 — PuraStat-OM (October 8, 2021)
  • K203091 — MucoLock Oral Gel (February 12, 2021)
  • K202000 — Silatrix Oral Gel (November 20, 2020)

FDA data resources