Cleared Traditional

K123697 - MATRICEL DENTAL BARRIER MEMBRANE

K123697 is an FDA 510(k) clearance for MATRICEL DENTAL BARRIER MEMBRANE, manufactured by Matricel GmbH. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K123697 · Matricel GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
448d
Days
Class 2
Risk

K123697 is an FDA 510(k) clearance for the MATRICEL DENTAL BARRIER MEMBRANE. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Matricel GmbH (Herzogenrath, DE). The FDA issued a Cleared decision on February 24, 2014 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K123697

510(k) Number K123697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2012
Decision Date February 24, 2014
Days to Decision 448 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
320d slower than avg
Panel avg: 128d · This submission: 448d
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 56
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K123697.
GUIDOSS
K133507 · Nibec Co., Ltd. · 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
MESOTHELIUM DENTAL MEMBRANE
K121310 · Kensey Nash Corporation · Jul 2013
COLLADENTAL BARRIER
K100695 · Collamatrix, Inc. · Jan 2013
COVAMAX RESORBABLE COLLAGEN MEMBRANE
K103087 · Biom'Up Sas · Aug 2011
K123697 · MATRICEL DENTAL BARRIER MEMBRANE
Download PDF FDA Summary Matricel GmbH