NPK · Class II · 21 CFR 872.3930

FDA Product Code NPK: Barrier, Synthetic, Intraoral

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.

Leading manufacturers include W.L. Gore & Associates, Inc., Porex Surgical, Inc. and Osteogenics Biomedical, Inc..

31
Total
31
Cleared
240d
Avg days
1986
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Barrier, Synthetic, Intraoral Devices (Product Code NPK)

31 devices
1–24 of 31
Cleared Dec 08, 2023
Lumina-PTFE Titanium
K221851
Criteria Industria E Comercio DE Produtos Medicinais
Dental · 529d
Cleared May 11, 2023
OpenTex
K222549
Purgo Biologics, Inc.
Dental · 261d
Cleared Feb 24, 2023
InnoGenic Non-resorbable Membrane
K211554
Cowellmedi Co., Ltd.
Dental · 646d
Cleared Aug 18, 2022
Bio-MEM Ti Reinforced Membrane
K210797
B&Medi Co., Ltd.
Dental · 520d
Cleared Jan 23, 2021
Cytoplast Titanium-Reinforced PTFE Membranes
K201187
Osteogenics Biomedical, Inc.
Dental · 267d
Cleared Oct 19, 2017
RPM Reinforced PTFE Mesh
K171774
Osteogenics Biomedical, Inc.
Dental · 127d
Cleared Sep 08, 2016
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
K160493
Salvin Dental Specialties
Dental · 199d
Cleared Nov 19, 2015
Cytoflex Tefguard Ti-Enforced Membrane
K151344
Unicare Biomedical, Inc.
Dental · 184d
Cleared Apr 13, 2015
Neoss Ti Reinforced Membrane
K143327
Neoss, Ltd.
Dental · 144d
Cleared Oct 29, 2013
GUIDOR BIORESORBABLE MATRIX BARRIER
K132325
Sunstar Americas, Inc.
Dental · 95d
Cleared Jan 07, 2011
MEDPOR CONTAIN CAN IMPLANT
K102184
Porex Surgical, Inc.
Dental · 158d
Cleared Mar 19, 2010
MEDPOR CONTAIN IMPLANT
K091120
Porex Surgical, Inc.
Dental · 336d
Cleared May 22, 2009
STRAUMANN MEMBRAGEL
K082111
Institut Straumann AG
Dental · 298d
Cleared Jun 15, 2005
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
K051267
W.L. Gore & Associates, Inc.
Dental · 30d
Cleared Mar 31, 2004
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
K033074
Inion , Ltd.
Dental · 184d
Cleared Apr 09, 1999
BIOMESH BIODEGRADABLE GTR BARRIER
K990363
Samyang Corp.
Dental · 63d
Cleared Sep 08, 1998
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT
K982865
Atrix Laboratories, Inc.
Dental · 26d
Cleared Mar 03, 1998
IMTEC/BIOBARRIER MEMBRANE
K974752
Imtec Corp.
Dental · 74d
Cleared Aug 26, 1997
IMTEC BIOBARRIER MEMBRANE
K972240
Imtec Corp.
Dental · 71d
Cleared Jun 11, 1997
BIO-GIDE RESORBABLE BILAYER MEMBRANE
K960724
Geistlich-Pharma
Dental · 475d
Cleared Apr 30, 1997
TEFGEN - LS
K965205
American Custom Medical, Inc.
Dental · 125d
Cleared Feb 10, 1997
TEFGEN GUIDED TISSUE MEMBRANE
K964656
American Custom Medical, Inc.
Dental · 82d
Cleared May 20, 1996
VICRYL PERIDONTAL MESH
K955646
Ethicon, Inc.
Dental · 160d
Cleared Apr 15, 1996
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
K960292
W.L. Gore & Associates, Inc.
Dental · 84d

About Product Code NPK - Regulatory Context

510(k) Submission Activity

31 total 510(k) submissions under product code NPK since 1986, with 31 receiving FDA clearance (average review time: 240 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.