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510(k) K252425

Silatrix Oral Gel by Sa3, LLC — Product Code OLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2025
Date Received
August 1, 2025
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 by Sa3, LLC

  • K202000 — Silatrix Oral Gel (November 20, 2020)

Other clearances for product code OLR

  • K253758 — Dental Cone; Dental Sponge (December 18, 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)
  • K193336 — Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse (May 27, 2020)
  • K191987 — Orapeutic (November 27, 2019)