Medpor Contain Implant
FDA 510(k) K091120 · Porex Surgical, Inc.
510(k) numberK091120
Submission
- Device name
- Medpor Contain Implant
- Applicant
- Porex Surgical, Inc.
Newnan, GA, US - Received
- April 17, 2009
- Decision date
- March 19, 2010
- 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 |
| K143327 | Neoss Ti Reinforced MembraneNPK · Traditional | Neoss, Ltd. | 04/13/2015SE |
| K132325 | Guidor Bioresorbable Matrix BarrierNPK · Abbreviated | Sunstar Americas, Inc. | 10/29/2013SE |
More from Sunstar Americas, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102184 | Medpor Contain Can ImplantNPK · Traditional | 01/07/2011SE |
| K101835 | Medpor Fixation System-Cranial, Models 80080, 80079HBW · Traditional | 12/03/2010SE |
| K091807 | Medpor Fixation SystemJEY · Traditional | 06/28/2010SE |
| K083621 | Medpor Customized Surgical ImplantJOF · Traditional | 02/03/2009SE |
| K071335 | Medpor Attractor ImplantHPZ · Traditional | 08/08/2007SE |
| K052297 | Porex Electrosurgery NeedleGEI · Traditional | 03/28/2006SE |
| K040851 | Medpor Attractor Magnetic Coupling SystemHPZ · Traditional | 07/16/2004SE |
| K040364 | Medpor Craniofacial Implants with Embedded Titanium MeshFTM · Traditional | 06/30/2004SE |
| K021357 | Medpor Plus Orbital Volume Replacement ImpantHPZ · Traditional | 08/05/2002SE |
| K012350 | Medpor Plus Surgical Implant BiomaterialFWP · Traditional | 03/14/2002SE |
Questions and answers
When was Medpor Contain Implant cleared by the FDA?
Medpor Contain Implant (K091120) received a 510(k) decision of Substantially Equivalent on March 19, 2010, 336 days after the submission was received.
What is the product code of K091120?
The FDA product code is NPK – Barrier, Synthetic, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.