Cleared Traditional

K082058 - DYNAMATRIX

K082058 is an FDA 510(k) clearance for DYNAMATRIX, manufactured by Cook Biotech, Inc.. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K082058 · Cook Biotech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
73d
Days
Class 2
Risk

K082058 is an FDA 510(k) clearance for the DYNAMATRIX. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on October 2, 2008 after a review of 73 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 Cook Biotech, Inc. devices

FDA 510(k) Submission Details - K082058

510(k) Number K082058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2008
Decision Date October 02, 2008
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
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 49
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K082058.
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
COLLAGEN DENTAL MEMBRANE IV
K090216 · Collagen Matrix, Inc. · Sep 2009
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