Cleared Traditional

K090612 - BENACEL

K090612 · Unicare Biomedical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
140d
Days
-
Risk

K090612 is an FDA 510(k) clearance for the BENACEL. Classified as Oral Wound Dressing (product code OLR).

Submitted by Unicare Biomedical (Laguna Hills, US). The FDA issued a Cleared decision on July 24, 2009 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Unicare Biomedical devices

FDA 510(k) Submission Details - K090612

510(k) Number K090612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2009
Decision Date July 24, 2009
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 19
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K090612.
Orapeutic
K191987 · Forward Science · Nov 2019
OraCure
K183436 · Tbm Corporation · Sep 2019
SUNTOUCH Dental Dressing
K173196 · Huizhou Foryou Medical Devices Co., Ltd. · Jan 2018
ALOE THERAPY ORAL RINSE
K983182 · Carrington Laboratories, Inc. · Dec 1998
RADIACARE ORAL WOUND RINSE
K964852 · Carrington Laboratories, Inc. · Mar 1997