Cleared Traditional

K160493 - Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160493 · Salvin Dental Specialties · Dental device
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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

Submission Details

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.

Device Classification

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 30
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K160493.
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Bio-MEM Ti Reinforced Membrane
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Cytoplast Titanium-Reinforced PTFE Membranes
K201187 · Osteogenics Biomedical, Inc. · Jan 2021