Cleared Traditional

K102531 - MUCOGRAFT

K102531 is an FDA 510(k) clearance for MUCOGRAFT, manufactured by Ed. Geistlich Soehne AG Fur Chemische Industrie. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K102531 · Ed. Geistlich Soehne AG Fur Chemische Industrie · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
75d
Days
Class 2
Risk

K102531 is an FDA 510(k) clearance for the MUCOGRAFT. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Ed. Geistlich Soehne AG Fur Chemische Industrie (Washington, US). The FDA issued a Cleared decision on November 17, 2010 after a review of 75 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 Ed. Geistlich Soehne AG Fur Chemische Industrie devices

FDA 510(k) Submission Details - K102531

510(k) Number K102531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2010
Decision Date November 17, 2010
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
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 37
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K102531.
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
K140518 · Geistlich Pharma AG · Jul 2014
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
K110600 · Collagen Matrix, Inc. · Jul 2011
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
K102307 · Genoss Co., Ltd. · May 2011
COLLAGEN DENTAL MEMBRANE V
K100156 · Collagen Matrix, Inc. · Aug 2010
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
K091192 · Kensey Nash Corp. · Nov 2009
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
K090919 · Kensey Nash Corp. · Oct 2009