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510(k) K241283

Elemental Granulate by Zinkh NV — Product Code OLR

K241283 is an FDA 510(k) premarket notification submitted by Zinkh NV for the device "Elemental Granulate". The FDA issued a decision of Substantially Equivalent on January 3, 2025. The device falls under product code OLR (Oral Wound Dressing), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2025
Date Received
May 7, 2024
Clearance Type
Traditional
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)
  • K253758 — Dental Cone; Dental Sponge (December 18, 2025)
  • K252425 — Silatrix Oral Gel (October 23, 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