NPK — Barrier, Synthetic, Intraoral Class II
FDA product code NPK covers "Barrier, Synthetic, Intraoral", a Class II medical device regulated under 21 CFR 872.3930. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |