Cleared Traditional

K082111 - STRAUMANN MEMBRAGEL

K082111 is an FDA 510(k) clearance for STRAUMANN MEMBRAGEL, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code NPK cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K082111 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
298d
Days
Class 2
Risk

K082111 is an FDA 510(k) clearance for the STRAUMANN MEMBRAGEL. Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by Institut Straumann AG (Andover, US). The FDA issued a Cleared decision on May 22, 2009 after a review of 298 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 Institut Straumann AG devices

FDA 510(k) Submission Details - K082111

510(k) Number K082111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2008
Decision Date May 22, 2009
Days to Decision 298 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
171d slower than avg
Panel avg: 127d · This submission: 298d
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 27
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K082111.
GUIDOR BIORESORBABLE MATRIX BARRIER
K132325 · Sunstar Americas, Inc. · Oct 2013
MEDPOR CONTAIN CAN IMPLANT
K102184 · Porex Surgical, Inc. · Jan 2011
MEDPOR CONTAIN IMPLANT
K091120 · Porex Surgical, Inc. · Mar 2010
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
K051267 · W.L. Gore & Associates, Inc. · Jun 2005
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
K033074 · Inion , Ltd. · Mar 2004
BIOMESH BIODEGRADABLE GTR BARRIER
K990363 · Samyang Corp. · Apr 1999