Cleared Traditional

K071555 - FORTAGEN ORAL MEMBRANE

K071555 is an FDA 510(k) clearance for FORTAGEN ORAL MEMBRANE, manufactured by Organogenesis, Inc.. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K071555 · Organogenesis, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
84d
Days
Class 2
Risk

K071555 is an FDA 510(k) clearance for the FORTAGEN ORAL MEMBRANE. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on August 30, 2007 after a review of 84 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 Organogenesis, Inc. devices

FDA 510(k) Submission Details - K071555

510(k) Number K071555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2007
Decision Date August 30, 2007
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 33
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K071555.
COLLAGEN DENTAL MEMBRANE V
K100156 · Collagen Matrix, Inc. · Aug 2010
COLLAGEN DENTAL MEMBRANE IV
K090216 · Collagen Matrix, Inc. · Sep 2009
DYNAMATRIX
K082058 · Cook Biotech, Inc. · Oct 2008
COLLAGEN DENTAL MEMBRANE III
K062846 · Collagen Matrix, Inc. · Oct 2006
COLLAGEN DENTAL MENBRANE - CONFORMABLE II
K062881 · Collagen Matrix, Inc. · Oct 2006
SURGISIS GUIDED TISSUE REGENERATION MATRIX
K010952 · Cook Biotech, Inc. · Jun 2002