Cleared Traditional

K073097 - TUTODENT DENTAL MEMBRANE

K073097 is an FDA 510(k) clearance for TUTODENT DENTAL MEMBRANE, manufactured by Tutogen Medical U.S., Inc.. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K073097 · Tutogen Medical U.S., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
193d
Days
Class 2
Risk

K073097 is an FDA 510(k) clearance for the TUTODENT DENTAL MEMBRANE. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Tutogen Medical U.S., Inc. (Alachua, US). The FDA issued a Cleared decision on May 12, 2008 after a review of 193 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.

View all Tutogen Medical U.S., Inc. devices

FDA 510(k) Submission Details - K073097

510(k) Number K073097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2007
Decision Date May 12, 2008
Days to Decision 193 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
66d slower than avg
Panel avg: 127d · This submission: 193d
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 K073097.
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
K090919 · Kensey Nash Corp. · Oct 2009
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