Cleared Traditional

K042197 - BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION

K042197 is an FDA 510(k) clearance for BIO-GIDE RESORBABLE BILAYER MEMBRANE FO..., 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 94-day FDA review.

K042197 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Dental device
Download Printable Device Report (PDF)
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Nov 2004
Decision
94d
Days
Class 2
Risk

K042197 is an FDA 510(k) clearance for the BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION. 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 November 15, 2004 after a review of 94 days - within the typical 510(k) review window.

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 Ed. Geistlich Soehne AG Fuer Chemische Industrie devices

FDA 510(k) Submission Details - K042197

510(k) Number K042197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2004
Decision Date November 15, 2004
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
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 K042197.
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
COLLAGEN DENTAL MEMBRANE
K011695 · Collagen Matrix, Inc. · Aug 2001
COLLAGEN PERIODONTAL MEMBRANE
K003339 · Collagen Matrix, Inc. · Jan 2001