Cleared Traditional

K082553 - REXASTOM ORAL EASE

K082553 · Rexaderm, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
79d
Days
-
Risk

K082553 is an FDA 510(k) clearance for the REXASTOM ORAL EASE. Classified as Oral Wound Dressing (product code OLR).

Submitted by Rexaderm, Inc. (Northbrook, US). The FDA issued a Cleared decision on November 21, 2008 after a review of 79 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 - K082553

510(k) Number K082553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2008
Decision Date November 21, 2008
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 K082553.
PERIOPATCH
K103054 · Izun Pharmaceuticals Corporation · Feb 2011
BENACEL
K090612 · Unicare Biomedical · Jul 2009
GELX ORAL GEL
K081372 · Bmg Pharma, LLC · Feb 2009
CARAPASTE ORAL WOUND DRESSING
K082856 · Mcgrath Pharmaceuticals, Inc. · Oct 2008
ULCELOOCIN ORAL ULCER PATCH
K070842 · Sunshine International Group, Inc. · Jun 2007
GENGIGEL MOUTHRINSE
K053342 · Ricerfarma Srl · Mar 2007
K082553 · REXASTOM ORAL EASE
Download PDF FDA Summary Rexaderm, Inc.