Barrier, Synthetic, Intraoral
The synthetic intraoral barrier is a dental implant device made of synthetic materials such as PTFE, intended to aid in guided tissue and bone regeneration procedures by acting as a stable barrier to contain bone graft materials during periodontal or implant surgery. It is classified as FDA Class 2 under regulation 872.3930 in the Dental specialty, requiring 510(k) clearance, and carries an implant flag. Product code NPK is not eligible for third-party review.
Research product code NPK in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NPK
- Device Class
- FDA class 2
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 31 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221851 | Lumina-PTFE Titanium | Dec 08, 2023 | Substantially Equivalent | Criteria Industria E Comercio DE Produtos Medicinais |
| K222549 | OpenTex | May 11, 2023 | Substantially Equivalent | Purgo Biologics, Inc. |
| K211554 | InnoGenic Non-resorbable Membrane | Feb 24, 2023 | Substantially Equivalent | Cowellmedi Co., Ltd. |
| K210797 | Bio-MEM Ti Reinforced Membrane | Aug 18, 2022 | Substantially Equivalent | B&Medi Co., Ltd. |
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Jan 23, 2021 | Substantially Equivalent | Osteogenics Biomedical, Inc. |
| K171774 | RPM Reinforced PTFE Mesh | Oct 19, 2017 | Substantially Equivalent | Osteogenics Biomedical, Inc. |
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm | Sep 08, 2016 | Substantially Equivalent | Salvin Dental Specialties |
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Nov 19, 2015 | Substantially Equivalent | Unicare Biomedical, Inc. |
| K143327 | Neoss Ti Reinforced Membrane | Apr 13, 2015 | Substantially Equivalent | Neoss, Ltd. |
| K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | Oct 29, 2013 | Substantially Equivalent | Sunstar Americas, Inc. |
| K102184 | MEDPOR CONTAIN CAN IMPLANT | Jan 07, 2011 | Substantially Equivalent | Porex Surgical, Inc. |
| K101956 | STRAUMANN MEMBRAGEL | Dec 16, 2010 | Substantially Equivalent | Straumann USA (On Behalf of Institut Straumann Ag) |
| K091120 | MEDPOR CONTAIN IMPLANT | Mar 19, 2010 | Substantially Equivalent | Porex Surgical, Inc. |
| K082111 | STRAUMANN MEMBRAGEL | May 22, 2009 | Substantially Equivalent | Institut Straumann AG |
| K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE | Jun 15, 2005 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K033074 | INION GTR BIODEGRADABLE MEMBRANE SYSTEM | Mar 31, 2004 | Substantially Equivalent | Inion , Ltd. |
| K990363 | BIOMESH BIODEGRADABLE GTR BARRIER | Apr 09, 1999 | Substantially Equivalent | Samyang Corp. |
| K982865 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT | Sep 08, 1998 | Substantially Equivalent | Atrix Laboratories, Inc. |
| K974752 | IMTEC/BIOBARRIER MEMBRANE | Mar 03, 1998 | Substantially Equivalent | Imtec Corp. |
| K972240 | IMTEC BIOBARRIER MEMBRANE | Aug 26, 1997 | Substantially Equivalent | Imtec Corp. |
| K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE | Jun 11, 1997 | Substantially Equivalent | Geistlich-Pharma |
| K965205 | TEFGEN - LS | Apr 30, 1997 | Substantially Equivalent | American Custom Medical, Inc. |
| K964656 | TEFGEN GUIDED TISSUE MEMBRANE | Feb 10, 1997 | Substantially Equivalent | American Custom Medical, Inc. |
| K955646 | VICRYL PERIDONTAL MESH | May 20, 1996 | Substantially Equivalent | ETHICON, Inc. |
| K960292 | GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS | Apr 15, 1996 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K955838 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) | Mar 21, 1996 | Substantially Equivalent | Atrix Laboratories, Inc. |
| K935137 | TEFGEN-FD | Aug 15, 1994 | Substantially Equivalent | American Custom Medical, Inc. |
| K922627 | GORE-TEX REGENERATIVE MATERIAL | Jun 10, 1994 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K933541 | GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS | Nov 30, 1993 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
| K912724 | GUIDOR(TM) | May 13, 1993 | Substantially Equivalent for Some Indications | Procordia Oratech AB |
| K854299 | GORE-TEX PERIODONTAL MATERIAL | May 19, 1986 | Substantially Equivalent | W. L. Gore & Associates, Inc. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.