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510(k) K193336

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse by Synedgen, Inc. — Product Code OLR

K193336 is an FDA 510(k) premarket notification submitted by Synedgen, Inc. for the device "Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse". The FDA issued a decision of Substantially Equivalent on May 27, 2020. The device falls under product code OLR (Oral Wound Dressing), a Class U device. Synedgen, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2020
Date Received
December 2, 2019
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 Synedgen, Inc.

  • K172338 — Catasyn Advanced Technology Wound Hydrogel (February 21, 2018)
  • K143444 — SynePure Wound Cleanser (August 21, 2015)

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)
  • 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)

FDA data resources