Cleared Traditional

K090919 - KENSEY NASH FIBRILLAR COLLAGEN DENTAL M...

K090919 is an FDA 510(k) clearance for KENSEY NASH FIBRILLAR COLLAGEN DENTAL M..., manufactured by Kensey Nash Corp.. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K090919 · Kensey Nash Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
184d
Days
Class 2
Risk

K090919 is an FDA 510(k) clearance for the KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on October 2, 2009 after a review of 184 days - an extended review cycle.

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 Corp. devices

FDA 510(k) Submission Details - K090919

510(k) Number K090919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2009
Decision Date October 02, 2009
Days to Decision 184 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 127d · This submission: 184d
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 35
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K090919.
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
K102307 · Genoss Co., Ltd. · May 2011
COLLAGEN DENTAL MEMBRANE V
K100156 · Collagen Matrix, Inc. · Aug 2010
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
K091192 · Kensey Nash Corp. · Nov 2009
COLLAGEN DENTAL MEMBRANE IV
K090216 · Collagen Matrix, Inc. · Sep 2009
DYNAMATRIX
K082058 · Cook Biotech, Inc. · Oct 2008
COLLAGEN DENTAL MEMBRANE III
K062846 · Collagen Matrix, Inc. · Oct 2006