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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 128d · 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 56
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K042197.
MUCOGRAFT
K061244 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Jun 2006
OSSIX -PLUS
K053260 · Colbar Lifescience , Ltd. · Feb 2006
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
K050446 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Aug 2005
MUCOGRAFT
K012423 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · Jan 2003
SURGISIS GUIDED TISSUE REGENERATION MATRIX
K010952 · Cook Biotech, Inc. · Jun 2002
COLLAGEN DENTAL MEMBRANE
K011695 · Collagen Matrix, Inc. · Aug 2001
K042197 · BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION
Download PDF FDA Summary Ed. Geistlich Soehne …