Cleared Traditional

K053342 - GENGIGEL MOUTHRINSE

K053342 · Ricerfarma Srl · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
467d
Days
-
Risk

K053342 is an FDA 510(k) clearance for the GENGIGEL MOUTHRINSE. Classified as Oral Wound Dressing (product code OLR).

Submitted by Ricerfarma Srl (Catonsville, US). The FDA issued a Cleared decision on March 13, 2007 after a review of 467 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K053342

510(k) Number K053342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2005
Decision Date March 13, 2007
Days to Decision 467 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
352d slower than avg
Panel avg: 115d · This submission: 467d
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 K053342.
REXASTOM ORAL EASE
K082553 · Rexaderm, Inc. · Nov 2008
CARAPASTE ORAL WOUND DRESSING
K082856 · Mcgrath Pharmaceuticals, Inc. · Oct 2008
ULCELOOCIN ORAL ULCER PATCH
K070842 · Sunshine International Group, Inc. · Jun 2007
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
K053342 · GENGIGEL MOUTHRINSE
Download PDF FDA Summary Ricerfarma Srl