Cleared Special

K062881 - COLLAGEN DENTAL MENBRANE - CONFORMABLE II

K062881 is an FDA 510(k) clearance for COLLAGEN DENTAL MENBRANE - CONFORMABLE II, manufactured by Collagen Matrix, Inc.. The device is a Class 2 Dental device with product code NPL cleared through the Special 510(k) pathway after a 15-day FDA review.

K062881 · Collagen Matrix, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
15d
Days
Class 2
Risk

K062881 is an FDA 510(k) clearance for the COLLAGEN DENTAL MENBRANE - CONFORMABLE II. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on October 11, 2006 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062881

510(k) Number K062881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2006
Decision Date October 11, 2006
Days to Decision 15 days
Submission Type Special
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
113d faster than avg
Panel avg: 128d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 57
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K062881.
TUTODENT DENTAL MEMBRANE
K073097 · Tutogen Medical U.S., Inc. · May 2008
FORTAGEN ORAL MEMBRANE
K071555 · Organogenesis, Inc. · Aug 2007
COLLAGEN DENTAL MEMBRANE III
K062846 · Collagen Matrix, Inc. · Oct 2006
MUCOGRAFT
K061244 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Jun 2006
OSSIX -PLUS
K053260 · Colbar Lifescience , Ltd. · Feb 2006
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
K050446 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Aug 2005
K062881 · COLLAGEN DENTAL MENBRANE - CONFORMABLE II
Download PDF FDA Summary Collagen Matrix, Inc.