Cleared Traditional

K073711 - MUCOGRAFT COLLAGEN MATRIX

K073711 is an FDA 510(k) clearance for MUCOGRAFT COLLAGEN MATRIX, manufactured by Ed. Geistlich Soehne AG Fuer Chemische Industrie. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K073711 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
151d
Days
Class 2
Risk

K073711 is an FDA 510(k) clearance for the MUCOGRAFT COLLAGEN MATRIX. 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 May 30, 2008 after a review of 151 days - an extended review 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: 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.

FDA 510(k) Submission Details - K073711

510(k) Number K073711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2007
Decision Date May 30, 2008
Days to Decision 151 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
23d slower than avg
Panel avg: 128d · This submission: 151d
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 K073711.
COLLAGEN DENTAL MEMBRANE IV
K090216 · Collagen Matrix, Inc. · Sep 2009
DYNAMATRIX
K082058 · Cook Biotech, Inc. · Oct 2008
OTA COLLAGEN BIOMATERIAL
K073685 · Osseous Technologies of America · Aug 2008
TUTODENT DENTAL MEMBRANE
K073097 · Tutogen Medical U.S., Inc. · May 2008
FORTAGEN ORAL MEMBRANE
K071555 · Organogenesis, Inc. · Aug 2007
COLLAGEN DENTAL MEMBRANE III
K062846 · Collagen Matrix, Inc. · Oct 2006
K073711 · MUCOGRAFT COLLAGEN MATRIX
Download PDF FDA Summary Ed. Geistlich Soehne …