Cleared Traditional

K011695 - COLLAGEN DENTAL MEMBRANE

K011695 is an FDA 510(k) clearance for COLLAGEN DENTAL MEMBRANE, manufactured by Collagen Matrix, Inc.. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K011695 · Collagen Matrix, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
68d
Days
Class 2
Risk

K011695 is an FDA 510(k) clearance for the COLLAGEN DENTAL MEMBRANE. 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 August 7, 2001 after a review of 68 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Collagen Matrix, Inc. devices

FDA 510(k) Submission Details - K011695

510(k) Number K011695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2001
Decision Date August 07, 2001
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
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 45
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K011695.
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
K050446 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Aug 2005
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION
K042197 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Nov 2004
SURGISIS GUIDED TISSUE REGENERATION MATRIX
K010952 · Cook Biotech, Inc. · Jun 2002
COLLAGEN PERIODONTAL MEMBRANE
K003339 · Collagen Matrix, Inc. · Jan 2001