Cleared Traditional

MUCOGRAFT (K012423) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012423 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
543d
Days
Class 2
Risk

K012423 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 Fuer Chemische Industrie (Washington, US). The FDA issued a Cleared decision on January 24, 2003 after a review of 543 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.

View all Ed. Geistlich Soehne AG Fuer Chemische Industrie devices

Submission Details

510(k) Number K012423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date January 24, 2003
Days to Decision 543 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
416d slower than avg
Panel avg: 127d · This submission: 543d
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 56
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K012423.
Jason membrane
K242817 · Botiss Biomaterials GmbH · Dec 2025
Augmented Gingival Matrix
K250512 · Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · Dec 2025
Geistlich Mucograft® /Geistlich Mucograft® Seal
K252253 · Geistlich Pharma AG · Nov 2025
Geistlich Bio-Gide
K251062 · Geistlich Pharma AG · Aug 2025
SwissMembrane X
K250833 · Geistlich Pharma AG · Apr 2025
Soft Tissue Augmentation Resorbable Matrix
K233203 · Collagen Matrix, Inc. · May 2024