Cleared Traditional

K130959 - AFTAMED MOUTHWASH

Also marketed or referenced as:
AFTAMED GEL AFTAMED SPRAY AFTAMED SHIELD AFTAMED JUNIOR GEL
K130959 · Bioplax Limited · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
364d
Days
-
Risk

K130959 is an FDA 510(k) clearance for the AFTAMED MOUTHWASH. Classified as Oral Wound Dressing (product code OLR).

Submitted by Bioplax Limited (Bellingham, US). The FDA issued a Cleared decision on April 4, 2014 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K130959

510(k) Number K130959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2013
Decision Date April 04, 2014
Days to Decision 364 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
249d slower than avg
Panel avg: 115d · This submission: 364d
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 K130959.
Orapeutic
K191987 · Forward Science · Nov 2019
OraCure
K183436 · Tbm Corporation · Sep 2019
SUNTOUCH Dental Dressing
K173196 · Huizhou Foryou Medical Devices Co., Ltd. · Jan 2018
AONGEN DENTAL COLLAGEN MATRIX
K112568 · Aeon Astron Europe B.V. · Mar 2012
EPISIL
K101769 · Camurus AB · Sep 2011
PERIOPATCH
K110750 · Mis Implants Technologies , Ltd. · Apr 2011
K130959 · AFTAMED MOUTHWASH
Download PDF FDA Summary Bioplax Limited