Cleared Traditional

K110750 - PERIOPATCH (FDA 510(k) Clearance)

K110750 · Mis Implants Technologies , Ltd. · General & Plastic Surgery device
Apr 2011
Decision
42d
Days
-
Risk

K110750 is an FDA 510(k) clearance for the PERIOPATCH. Classified as Oral Wound Dressing (product code OLR).

Submitted by Mis Implants Technologies , Ltd. (Bar Lev Industrial Park, IL). The FDA issued a Cleared decision on April 28, 2011 after a review of 42 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.

Submission Details

510(k) Number K110750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2011
Decision Date April 28, 2011
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 132d · This submission: 42d
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.