Atlas FDA

NPK

31 FDA 510(k) clearances · Product code

160 daysmedian time to decision
529 days90th percentile
31clearances measured

FDA profile

Official device name
Barrier, Synthetic, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Medical specialty
Dental
Flags
Implant
FDA 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.
Adverse events (MAUDE)
1996: 1 · 2010: 13 · 2011: 35 · 2012: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Lumina-PTFE Titanium (K221851)Criteria Industria E Comercio DE Produtos Medicinais2023-12-08
OpenTex (K222549)Purgo Biologics, Inc.2023-05-11
InnoGenic Non-resorbable Membrane (K211554)Cowellmedi Co., Ltd.2023-02-24
Bio-MEM Ti Reinforced Membrane (K210797)B&Medi Co., Ltd.2022-08-18
Cytoplast Titanium-Reinforced PTFE Membranes (K201187)Osteogenics Biomedical, Inc.2021-01-23
RPM Reinforced PTFE Mesh (K171774)Osteogenics Biomedical, Inc.2017-10-19
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm (K160493)Salvin Dental Specialties2016-09-08
Cytoflex Tefguard Ti-Enforced Membrane (K151344)Unicare Biomedical, Inc.2015-11-19
Neoss Ti Reinforced Membrane (K143327)Neoss, Ltd.2015-04-13
GUIDOR BIORESORBABLE MATRIX BARRIER (K132325)Sunstar Americas, Inc.2013-10-29
MEDPOR CONTAIN CAN IMPLANT (K102184)Porex Surgical, Inc.2011-01-07
STRAUMANN MEMBRAGEL (K101956)Straumann USA (On Behalf of Institut Straumann Ag)2010-12-16
MEDPOR CONTAIN IMPLANT (K091120)Porex Surgical, Inc.2010-03-19
STRAUMANN MEMBRAGEL (K082111)Institut Straumann AG2009-05-22
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE (K051267)W. L. Gore & Associates, Inc.2005-06-15
INION GTR BIODEGRADABLE MEMBRANE SYSTEM (K033074)Inion , Ltd.2004-03-31
BIOMESH BIODEGRADABLE GTR BARRIER (K990363)Samyang Corp.1999-04-09
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT (K982865)Atrix Laboratories, Inc.1998-09-08
IMTEC/BIOBARRIER MEMBRANE (K974752)Imtec Corp.1998-03-03
IMTEC BIOBARRIER MEMBRANE (K972240)Imtec Corp.1997-08-26
BIO-GIDE RESORBABLE BILAYER MEMBRANE (K960724)Geistlich-Pharma1997-06-11
TEFGEN - LS (K965205)American Custom Medical, Inc.1997-04-30
TEFGEN GUIDED TISSUE MEMBRANE (K964656)American Custom Medical, Inc.1997-02-10
VICRYL PERIDONTAL MESH (K955646)ETHICON, Inc.1996-05-20
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS (K960292)W. L. Gore & Associates, Inc.1996-04-15
ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) (K955838)Atrix Laboratories, Inc.1996-03-21
TEFGEN-FD (K935137)American Custom Medical, Inc.1994-08-15
GORE-TEX REGENERATIVE MATERIAL (K922627)W. L. Gore & Associates, Inc.1994-06-10
GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS (K933541)W. L. Gore & Associates, Inc.1993-11-30
GUIDOR(TM) (K912724)Procordia Oratech AB1993-05-13
GORE-TEX PERIODONTAL MATERIAL (K854299)W. L. Gore & Associates, Inc.1986-05-19

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Every clearance here is in the API, with alerts when new ones post.