Cleared Traditional

K140518 - GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER

K140518 is an FDA 510(k) clearance for GEISTLICH MUCOGRAFT: 15 X 20 MM, manufactured by Geistlich Pharma AG. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K140518

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
Combination Product No
PCCP Authorized No
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.

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 K140518.
Collagen Dental Membrane - Conformable IIBP
K142496 · Collagen Matrix, Inc. · Nov 2014
GUIDOSS
K133507 · Nibec Co., Ltd. · Nov 2014
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
K141909 · Collagen Matrix, Inc. · Nov 2014
MATRICEL DENTAL BARRIER MEMBRANE
K123697 · Matricel GmbH · Feb 2014
MESOTHELIUM DENTAL MEMBRANE
K121310 · Kensey Nash Corporation · Jul 2013
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
K110600 · Collagen Matrix, Inc. · Jul 2011