Cleared Traditional

K160493 - Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 128d · 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 Consultant

Kapstone Medical
John Kapitan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NPK Barrier, Synthetic, Intraoral

All 29
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K160493.
Bio-MEM Ti Reinforced Membrane
K210797 · B&Medi Co., Ltd. · Aug 2022
Cytoplast Titanium-Reinforced PTFE Membranes
K201187 · Osteogenics Biomedical, Inc. · Jan 2021
RPM Reinforced PTFE Mesh
K171774 · Osteogenics Biomedical, Inc. · Oct 2017
Cytoflex Tefguard Ti-Enforced Membrane
K151344 · Unicare Biomedical, Inc. · Nov 2015
Neoss Ti Reinforced Membrane
K143327 · Neoss, Ltd. · Apr 2015
GUIDOR BIORESORBABLE MATRIX BARRIER
K132325 · Sunstar Americas, Inc. · Oct 2013