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., Osteogenics Biomedical, Inc. and B&Medi Co., Ltd..
31
Total
31
Cleared
240d
Avg days
1986
Since
Declining activity -
0 submissions in the last 2 years
vs 4 in the prior period
FDA 510(k) Cleared Barrier, Synthetic, Intraoral Devices (Product Code NPK)
31 devices
Cleared
Dec 08, 2023
Lumina-PTFE Titanium
Criteria Industria E Comercio DE Produtos Medicinais
Dental
529d
Cleared
May 11, 2023
OpenTex
Purgo Biologics, Inc.
Dental
261d
Cleared
Feb 24, 2023
InnoGenic Non-resorbable Membrane
Cowellmedi Co., Ltd.
Dental
646d
Cleared
Aug 18, 2022
Bio-MEM Ti Reinforced Membrane
B&Medi Co., Ltd.
Dental
520d
Cleared
Jan 23, 2021
Cytoplast Titanium-Reinforced PTFE Membranes
Osteogenics Biomedical, Inc.
Dental
267d
Cleared
May 22, 2009
STRAUMANN MEMBRAGEL
Institut Straumann AG
Dental
298d
Cleared
Jun 15, 2005
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
W.L. Gore & Associates, Inc.
Dental
30d
Cleared
May 20, 1996
VICRYL PERIDONTAL MESH
Ethicon, Inc.
Dental
160d
Cleared
Apr 15, 1996
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
W.L. Gore & Associates, Inc.
Dental
84d
Cleared
Jun 10, 1994
GORE-TEX REGENERATIVE MATERIAL
W.L. Gore & Associates, Inc.
Dental
737d
Cleared
Nov 30, 1993
GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS
W.L. Gore & Associates, Inc.
Dental
132d
Cleared
May 19, 1986
GORE-TEX PERIODONTAL MATERIAL
W.L. Gore & Associates, Inc.
Dental
206d
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 4 in the prior period.