Cleared Traditional

K160493 - Cytosurg non-resorbable PTFE Membrane

K160493 is an FDA 510(k) clearance for Cytosurg non-resorbable PTFE Membrane, manufactured by Salvin Dental Specialties. The device is a Class 2 Dental device with product code NPK cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K160493 · Salvin Dental Specialties · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
199d
Days
Class 2
Risk

K160493 is an FDA 510(k) clearance for the Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable P.... Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by Salvin Dental Specialties (Charlotte, US). The FDA issued a Cleared decision on September 8, 2016 after a review of 199 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 Salvin Dental Specialties devices

FDA 510(k) Submission Details - K160493

510(k) Number K160493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2016
Decision Date September 08, 2016
Days to Decision 199 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
72d slower than avg
Panel avg: 127d · This submission: 199d
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 K160493.
InnoGenic Non-resorbable Membrane
K211554 · Cowellmedi Co., Ltd. · Feb 2023
Bio-MEM Ti Reinforced Membrane
K210797 · B&Medi Co., Ltd. · Aug 2022
Cytoplast Titanium-Reinforced PTFE Membranes
K201187 · Osteogenics Biomedical, Inc. · Jan 2021
MEDPOR CONTAIN CAN IMPLANT
K102184 · Porex Surgical, Inc. · Jan 2011
MEDPOR CONTAIN IMPLANT
K091120 · Porex Surgical, Inc. · Mar 2010
STRAUMANN MEMBRAGEL
K082111 · Institut Straumann AG · May 2009