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510(k) K024180

ORAMAGICRX ORAL WOUND RINSE by Mpm Medical., Inc. — Product Code OLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2003
Date Received
December 18, 2002
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 Mpm Medical., Inc.

  • K060340 — ORAMAGIC PLUS ORAL WOUND RINSE (May 10, 2006)
  • K020540 — REGENECARE WOUND GEL (November 1, 2002)
  • K992074 — MPM REGENECARE WOUND GEL (December 23, 1999)
  • K962160 — MPM HYDROGEL DRESSING (NON-STERILE) (June 26, 1996)
  • K952276 — MPM HYDROGEL DRESSING (June 30, 1995)
  • K942798 — MPM HYDROGEL (July 11, 1994)
  • K930560 — MPM HYDROGEL SATURATED DRESSING (July 8, 1993)
  • K926044 — MPM WET DRESSING (SALINE) (April 8, 1993)

Other clearances for product code OLR

  • 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)
  • K202000 — Silatrix Oral Gel (November 20, 2020)
  • K193336 — Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse (May 27, 2020)