Cleared Traditional

K070842 - ULCELOOCIN ORAL ULCER PATCH

K070842 · Sunshine International Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
72d
Days
-
Risk

K070842 is an FDA 510(k) clearance for the ULCELOOCIN ORAL ULCER PATCH. Classified as Oral Wound Dressing (product code OLR).

Submitted by Sunshine International Group, Inc. (New York, US). The FDA issued a Cleared decision on June 7, 2007 after a review of 72 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 - K070842

510(k) Number K070842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2007
Decision Date June 07, 2007
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 K070842.
GELX ORAL GEL
K081372 · Bmg Pharma, LLC · Feb 2009
REXASTOM ORAL EASE
K082553 · Rexaderm, Inc. · Nov 2008
CARAPASTE ORAL WOUND DRESSING
K082856 · Mcgrath Pharmaceuticals, Inc. · Oct 2008
GENGIGEL MOUTHRINSE
K053342 · Ricerfarma Srl · Mar 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
K070842 · ULCELOOCIN ORAL ULCER PATCH
Download PDF FDA Summary Sunshine Internationa…