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

FDA 510(k) K160493 · Salvin Dental Specialties

Substantially Equivalent

510(k) numberK160493

Submission

Device name
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
Applicant
Salvin Dental Specialties
Charlotte, NC, US
Received
February 22, 2016
Decision date
September 8, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NPK – Barrier, Synthetic, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Specialty
Dental
Implant
Yes

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.

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K211554InnoGenic Non-resorbable MembraneNPK · Traditional Cowellmedi Co., Ltd.02/24/2023SE
K210797Bio-MEM Ti Reinforced MembraneNPK · Traditional B&Medi Co., Ltd.08/18/2022SE
K201187Cytoplast Titanium-Reinforced PTFE MembranesNPK · Traditional Osteogenics Biomedical, Inc.01/23/2021SE
K171774RPM Reinforced PTFE MeshNPK · Traditional Osteogenics Biomedical, Inc.10/19/2017SE
K151344Cytoflex Tefguard Ti-Enforced MembraneNPK · Traditional Unicare Biomedical, Inc.11/19/2015SE
K143327Neoss Ti Reinforced MembraneNPK · Traditional Neoss, Ltd.04/13/2015SE
K132325Guidor Bioresorbable Matrix BarrierNPK · Abbreviated Sunstar Americas, Inc.10/29/2013SE
K102184Medpor Contain Can ImplantNPK · Traditional Porex Surgical, Inc.01/07/2011SE

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Questions and answers

When was Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm cleared by the FDA?

Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm (K160493) received a 510(k) decision of Substantially Equivalent on September 8, 2016, 199 days after the submission was received.

What is the product code of K160493?

The FDA product code is NPK – Barrier, Synthetic, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.