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510(k) K024180

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

K024180 is an FDA 510(k) premarket notification submitted by Mpm Medical., Inc. for the device "ORAMAGICRX ORAL WOUND RINSE". The FDA issued a decision of Substantially Equivalent on March 14, 2003. The device falls under product code OLR (Oral Wound Dressing), a Class U device. Mpm Medical., Inc. has at least 8 other 510(k) clearances on record.

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

  • K260120 — NaturaJel™ Oral Wound Care Kit (August 5, 2026)
  • K251908 — Emanate Tray (July 29, 2026)
  • 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)

FDA data resources