NPK — Barrier, Synthetic, Intraoral Class II
Classification Details
- Product Code
- NPK
- Device Class
- Class II
- Regulation Number
- 872.3930
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221851 | criteria industria e comercio de produtos medicinais | Lumina-PTFE Titanium | December 8, 2023 |
| K222549 | purgo biologics | OpenTex | May 11, 2023 |
| K211554 | cowellmedi co | InnoGenic Non-resorbable Membrane | February 24, 2023 |
| K210797 | b and medi co | Bio-MEM Ti Reinforced Membrane | August 18, 2022 |
| K201187 | osteogenics biomedical | Cytoplast Titanium-Reinforced PTFE Membranes | January 23, 2021 |
| K171774 | osteogenics biomedical | RPM Reinforced PTFE Mesh | October 19, 2017 |
| K160493 | salvin dental specialties | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE | September 8, 2016 |
| K151344 | unicare biomedical | Cytoflex Tefguard Ti-Enforced Membrane | November 19, 2015 |
| K143327 | neoss | Neoss Ti Reinforced Membrane | April 13, 2015 |
| K132325 | sunstar americas | GUIDOR BIORESORBABLE MATRIX BARRIER | October 29, 2013 |
| K102184 | porex surgical | MEDPOR CONTAIN CAN IMPLANT | January 7, 2011 |
| K101956 | straumann usa (on behalf of institut straumann ag) | STRAUMANN MEMBRAGEL | December 16, 2010 |
| K091120 | porex surgical | MEDPOR CONTAIN IMPLANT | March 19, 2010 |
| K082111 | institut straumann | STRAUMANN MEMBRAGEL | May 22, 2009 |
| K051267 | w.l. gore and associates | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE | June 15, 2005 |
| K033074 | inion | INION GTR BIODEGRADABLE MEMBRANE SYSTEM | March 31, 2004 |
| K990363 | samyang | BIOMESH BIODEGRADABLE GTR BARRIER | April 9, 1999 |
| K982865 | atrix laboratories | ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT | September 8, 1998 |
| K974752 | imtec | IMTEC/BIOBARRIER MEMBRANE | March 3, 1998 |
| K972240 | imtec | IMTEC BIOBARRIER MEMBRANE | August 26, 1997 |