Cleared Traditional

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

K160493 · Salvin Dental Specialties · Dental

Sep 2016

Decision

199d

Days

Class 2

Risk

About This 510(k) Submission

K160493 is an FDA 510(k) clearance for the Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm, a Barrier, Synthetic, Intraoral (Class II — Special Controls, product code NPK), submitted by Salvin Dental Specialties (Charlotte, US). The FDA issued a Cleared decision on September 8, 2016, 199 days after receiving the submission on February 22, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K160493 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NPK — Barrier, Synthetic, Intraoral
Device Class	Class II — 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.