Cleared Traditional

K960724 - BIO-GIDE RESORBABLE BILAYER MEMBRANE

K960724 is an FDA 510(k) clearance for BIO-GIDE RESORBABLE BILAYER MEMBRANE, manufactured by Geistlich-Pharma. The device is a Class 2 Dental device with product code NPK cleared through the Traditional 510(k) pathway after a 475-day FDA review.

K960724 · Geistlich-Pharma · Dental device
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Jun 1997
Decision
475d
Days
Class 2
Risk

K960724 is an FDA 510(k) clearance for the BIO-GIDE RESORBABLE BILAYER MEMBRANE. Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by Geistlich-Pharma (Washington, US). The FDA issued a Cleared decision on June 11, 1997 after a review of 475 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Geistlich-Pharma devices

FDA 510(k) Submission Details - K960724

510(k) Number K960724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1996
Decision Date June 11, 1997
Days to Decision 475 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
348d slower than avg
Panel avg: 127d · This submission: 475d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPK Device Classification - Class 2, Special Controls

Product Code NPK Barrier, Synthetic, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials.
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 - NPK Barrier, Synthetic, Intraoral

All 17
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K960724.
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
K033074 · Inion , Ltd. · Mar 2004
IMTEC/BIOBARRIER MEMBRANE
K974752 · Imtec Corp. · Mar 1998
IMTEC BIOBARRIER MEMBRANE
K972240 · Imtec Corp. · Aug 1997
VICRYL PERIDONTAL MESH
K955646 · Ethicon, Inc. · May 1996
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
K960292 · W.L. Gore & Associates, Inc. · Apr 1996
GORE-TEX REGENERATIVE MATERIAL
K922627 · W.L. Gore & Associates, Inc. · Jun 1994