Neoss Ti Reinforced Membrane
FDA 510(k) K143327 · Neoss, Ltd.
510(k) numberK143327
Submission
- Device name
- Neoss Ti Reinforced Membrane
- Applicant
- Neoss, Ltd.
Harrogate, GB - Received
- November 20, 2014
- Decision date
- April 13, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K221851 | Lumina-PTFE TitaniumNPK · Traditional | Criteria Industria E Comercio DE Produtos… | 12/08/2023SE |
| K222549 | OpenTexNPK · Traditional | Purgo Biologics, Inc. | 05/11/2023SE |
| K211554 | InnoGenic Non-resorbable MembraneNPK · Traditional | Cowellmedi Co., Ltd. | 02/24/2023SE |
| K210797 | Bio-MEM Ti Reinforced MembraneNPK · Traditional | B&Medi Co., Ltd. | 08/18/2022SE |
| K201187 | Cytoplast Titanium-Reinforced PTFE MembranesNPK · Traditional | Osteogenics Biomedical, Inc. | 01/23/2021SE |
| K171774 | RPM Reinforced PTFE MeshNPK · Traditional | Osteogenics Biomedical, Inc. | 10/19/2017SE |
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE…NPK · Traditional | Salvin Dental Specialties | 09/08/2016SE |
| K151344 | Cytoflex Tefguard Ti-Enforced MembraneNPK · Traditional | Unicare Biomedical, Inc. | 11/19/2015SE |
| K132325 | Guidor Bioresorbable Matrix BarrierNPK · Abbreviated | Sunstar Americas, Inc. | 10/29/2013SE |
| K102184 | Medpor Contain Can ImplantNPK · Traditional | Porex Surgical, Inc. | 01/07/2011SE |
More from Porex Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K211396 | Neoss Individual ProstheticsNHA · Traditional | 05/17/2022SE |
| K201561 | Membrane Screws and Membrane TacksDZL · Traditional | 10/05/2020SE |
| K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)NHA · Traditional | 10/08/2015SE |
| K113376 | Neoss Proactive Tapered ImplantDZE · Traditional | 09/05/2012SE |
| K090452 | Neoss Implant System 03.25DZE · Traditional | 05/22/2009SE |
| K081851 | Neoss Access AbutmentsNHA · Traditional | 03/02/2009SE |
| K083561 | Neoss Proactive ImplantDZE · Special | 02/11/2009SE |
| K071838 | Neoss Various Titanium AbutmentsNHA · Traditional | 10/19/2007SE |
| K043195 | Neo Implant SystemDZE · Traditional | 03/07/2005SE |
Questions and answers
When was Neoss Ti Reinforced Membrane cleared by the FDA?
Neoss Ti Reinforced Membrane (K143327) received a 510(k) decision of Substantially Equivalent on April 13, 2015, 144 days after the submission was received.
What is the product code of K143327?
The FDA product code is NPK – Barrier, Synthetic, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.