Cleared Traditional

K160474 - DSM Biomedical Porcine Pericardium Dent...

K160474 is an FDA 510(k) clearance for DSM Biomedical Porcine Pericardium Dent..., manufactured by Kensey Nash Corporation Dba Dsm Biomedical. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K160474 · Kensey Nash Corporation Dba Dsm Biomedical · Dental device
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Jun 2016
Decision
109d
Days
Class 2
Risk

K160474 is an FDA 510(k) clearance for the DSM Biomedical Porcine Pericardium Dental Membrane. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Kensey Nash Corporation Dba Dsm Biomedical (Exton, US). The FDA issued a Cleared decision on June 7, 2016 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kensey Nash Corporation Dba Dsm Biomedical devices

FDA 510(k) Submission Details - K160474

510(k) Number K160474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date June 07, 2016
Days to Decision 109 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 127d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPL Device Classification - Class 2, Special Controls

Product Code NPL Barrier, Animal Source, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NPL Barrier, Animal Source, Intraoral

All 33
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K160474.
Straumann Jason Membrane
K173562 · Institut Straumann AG · Jul 2018
Geistlich Fibro-Gide
K171050 · Geistlich Pharma AG · Nov 2017
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
K171643 · Geistlich Pharma AG · Oct 2017
Collagen Dental Membrane - Conformable IIBP
K142496 · Collagen Matrix, Inc. · Nov 2014
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
K141909 · Collagen Matrix, Inc. · Nov 2014
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
K140518 · Geistlich Pharma AG · Jul 2014