RPM Reinforced PTFE Mesh
FDA 510(k) K171774 · Osteogenics Biomedical, Inc.
510(k) numberK171774
Submission
- Device name
- RPM Reinforced PTFE Mesh
- Applicant
- Osteogenics Biomedical, Inc.
Lubbock, TX, US - Received
- June 14, 2017
- Decision date
- October 19, 2017
- 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.
Other 510(k)s with product code NPK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K102184 | Medpor Contain Can ImplantNPK · Traditional | Porex Surgical, Inc. | 01/07/2011SE |
More from Porex Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201187 | Cytoplast Titanium-Reinforced PTFE MembranesNPK · Traditional | 01/23/2021SE |
| K093719 | Pro-Fix Precision Fixation System Model Pfm#, Pfb#, Pft#DZL · Traditional | 03/01/2010SE |
| K072076 | Cytoplast PTFE SutureNBY · Abbreviated | 10/31/2007SE |
| K013764 | Immix Bone Graft ExtenderKKY · Traditional | 05/16/2002SE |
| K003028 | Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HCNBY · Traditional | 11/24/2000SE |
| K993610 | Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250LYC · Traditional | 03/02/2000SE |
| K984230 | Osteo-Mesh TM-300JEY · Traditional | 02/04/1999SE |
Questions and answers
When was RPM Reinforced PTFE Mesh cleared by the FDA?
RPM Reinforced PTFE Mesh (K171774) received a 510(k) decision of Substantially Equivalent on October 19, 2017, 127 days after the submission was received.
What is the product code of K171774?
The FDA product code is NPK – Barrier, Synthetic, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.