Cleared Traditional

K140518 - GEISTLICH MUCOGRAFT: 15 X 20 MM

K140518 is the FDA 510(k) clearance for GEISTLICH MUCOGRAFT: 15 X 20 MM by Geistlich Pharma AG. It is a Class 2 Dental device (product code NPL) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K140518 · Geistlich Pharma AG · Dental device
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Jul 2014
Decision
140d
Days
Class 2
Risk

K140518 is an FDA 510(k) clearance for the GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Geistlich Pharma AG (Washington, US). The FDA issued a Cleared decision on July 18, 2014 after a review of 140 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 Geistlich Pharma AG devices

Submission Details

510(k) Number K140518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2014
Decision Date July 18, 2014
Days to Decision 140 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
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 28
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K140518.
Straumann Jason Membrane
K173562 · Institut Straumann AG · Jul 2018
Collagen Dental Membrane - Conformable IIBP
K142496 · Collagen Matrix, Inc. · Nov 2014
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
K141909 · Collagen Matrix, Inc. · Nov 2014
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
K110600 · Collagen Matrix, Inc. · Jul 2011
COLLAGEN DENTAL MEMBRANE V
K100156 · Collagen Matrix, Inc. · Aug 2010
COLLAGEN DENTAL MEMBRANE IV
K090216 · Collagen Matrix, Inc. · Sep 2009