Cleared Traditional

REXASTOM ORAL EASE (K082553) - FDA 510(k) Clearance

K082553 · Rexaderm, Inc. · General & Plastic Surgery device
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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.

View all Rexaderm, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 39
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K082553.
MuCover (proposed name) Oral Wound Dressing
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K253758 · Medizin Produkte Neustadt GmbH (Mpn) · Dec 2025
Silatrix Oral Gel
K252425 · Sa3, LLC · Oct 2025
Elemental Granulate
K241283 · Zinkh NV · Jan 2025
HealiAid Dental Collagen Wound Dressing
K230529 · Maxigen Biotech, Inc. · Nov 2023
PerioStom Dental Dressing
K221428 · Forward Science, LLC · Dec 2022