Cleared Traditional

K060340 - ORAMAGIC PLUS ORAL WOUND RINSE

K060340 · Mpm Medical., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
89d
Days
-
Risk

K060340 is an FDA 510(k) clearance for the ORAMAGIC PLUS ORAL WOUND RINSE. Classified as Oral Wound Dressing (product code OLR).

Submitted by Mpm Medical., Inc. (Monroe, US). The FDA issued a Cleared decision on May 10, 2006 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060340

510(k) Number K060340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2006
Decision Date May 10, 2006
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

OLR Device Classification - Class 0,

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 42
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K060340.
SOCK IT! ORAL PAIN GEL
K063148 · Merlin Group Dba Mcmerlin Dental Company · Jan 2007
MUGARD MUCOADHESIVE ORAL WOUND RINSE
K062795 · Access Pharmaceuticals, Inc. · Dec 2006
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
K060363 · Hemcon, Inc. · Jul 2006
ALOCLAIR ORAL SPRAY
K042722 · Sinclair Pharmaceuticals, Ltd. · Jan 2005
MUCOTROL CONCENTRATED ORAL GEL WAFER
K042400 · Belcher Pharmaceuticals, Inc. · Nov 2004
ALOCLAIR ORAL GEL
K040950 · Sinclair Pharmaceuticals, Ltd. · Jun 2004
K060340 · ORAMAGIC PLUS ORAL WOUND RINSE
Download PDF FDA Summary Mpm Medical., Inc.