Dental Device Guide
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Prosthetic devices · 21 CFR 872 Subpart D

Intraoral Synthetic Barrier

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.

FDA codeNPKClass221 CFR872.3930Pathway510(k)ImplantCategoryBone grafts & membranes
Companies listing it
2112 makers
Brands and models
23
510(k) clearances
314 in five years
FDA name
Barrier, Synthetic, Intraoral
1986: 11993: 21994: 21996: 31997: 41998: 21999: 12004: 12005: 12009: 12010: 22011: 12013: 12015: 22016: 12017: 12021: 12022: 12023: 319801990200020102020

510(k) clearances per year, 1976–2026

Companies that list NPK

21 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakerMembraGel · Synthetic Barrier, intraoral2122026
Cowellmedi Co., Ltd.South KoreaMakerInnoGenic Non-resorbable Membrane142025
Young Innovations IncUnited StatesMakerCytoSurg232025
PURGO BIOLOGICS Inc.South KoreaMakerCYTOSHIELD · OpenTex · TBS PTFE Membrane52024
Collagen Matrix, Inc.United StatesMakerGUIDOR ES Membrane · GUIDOR Resorbable Matrix Barrier202024
Beijing Naton Technology Group Co. Ltd.ChinaMakerInion GTR Accessory Instrument · Inion GTR Biodegradable Membrane System102025
Neoss ABSwedenMaker—102022
Unicare Biomedical, Inc.United StatesMakerCytoflex Ti-Enforced Membrane · Perforated Cytoflex Ti-Enforced Membrane92015
Osteogenics Biomedical, Inc.United StatesMakerRPM Reinforced PTFE Mesh52021
Life Science Outsourcing, Inc.United StatesMaker———
Criteria Industria e Comercio de Produtos Medicinais e OdontBrazilMakerLumina-PTFE Titanium——
Wesley Coe (Cambridge) Ltd.United KingdomMaker———
Nobel Biocare Services AGSwitzerlandContract manufacturercreos942026
StrykerUnited StatesContract manufacturerMEDPOR CONTAIN CAN Implant · MEDPOR CONTAIN Implant332024
Sotera Health LLCUnited StatesContract manufacturerbarrier, synthetic, intraoral Straumann MembraGel——
Sweden & Martina INCUnited StatesListerOPEN TEX——
STERIS CorporationUnited StatesContract sterilizer———
TBS DentalUnited StatesRepacker / relabelerPTFE Membrane——
HANSAMED LIMITED dba CITAGENIXCanadaForeign exporterOpentex——
Steritec Services LLCUnited StatesContract sterilizerdental bone plate——
GAMMATOM SrlItalyContract sterilizer———

510(k) clearances

Decided510(k)DeviceApplicant
8 Dec 2023K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais
11 May 2023K222549OpenTexPURGO BIOLOGICS Inc.
24 Feb 2023K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.
18 Aug 2022K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.
23 Jan 2021K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.
19 Oct 2017K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.
8 Sep 2016K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmYoung Innovations Inc
19 Nov 2015K151344Cytoflex Tefguard Ti-Enforced MembraneUnicare Biomedical, Inc.
13 Apr 2015K143327Neoss Ti Reinforced MembraneNeoss AB
29 Oct 2013K132325GUIDOR BIORESORBABLE MATRIX BARRIERSunstar Americas, Inc.
7 Jan 2011K102184MEDPOR CONTAIN CAN IMPLANTPorex Surgical, Inc.
16 Dec 2010K101956STRAUMANN MEMBRAGELStraumann USA (On Behalf of Institut Straumann Ag)
19 Mar 2010K091120MEDPOR CONTAIN IMPLANTPorex Surgical, Inc.
22 May 2009K082111STRAUMANN MEMBRAGELInstitut Straumann AG
15 Jun 2005K051267GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANEW. L. Gore & Associates, Inc.
31 Mar 2004K033074INION GTR BIODEGRADABLE MEMBRANE SYSTEMBeijing Naton Technology Group Co. Ltd.
9 Apr 1999K990363BIOMESH BIODEGRADABLE GTR BARRIERSamyang Corp.
8 Sep 1998K982865ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KITAtrix Laboratories, Inc.
3 Mar 1998K974752IMTEC/BIOBARRIER MEMBRANEImtec Corp.
26 Aug 1997K972240IMTEC BIOBARRIER MEMBRANEImtec Corp.
11 Jun 1997K960724BIO-GIDE RESORBABLE BILAYER MEMBRANEGeistlich Pharma AG
30 Apr 1997K965205TEFGEN - LSAmerican Custom Medical, Inc.
10 Feb 1997K964656TEFGEN GUIDED TISSUE MEMBRANEAmerican Custom Medical, Inc.
20 May 1996K955646VICRYL PERIDONTAL MESHETHICON, Inc.
15 Apr 1996K960292GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONSW. L. Gore & Associates, Inc.
21 Mar 1996K955838ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)Atrix Laboratories, Inc.
15 Aug 1994K935137TEFGEN-FDAmerican Custom Medical, Inc.
10 Jun 1994K922627GORE-TEX REGENERATIVE MATERIALW. L. Gore & Associates, Inc.
30 Nov 1993K933541GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONSW. L. Gore & Associates, Inc.
13 May 1993K912724GUIDOR(TM)Procordia Oratech AB
19 May 1986K854299GORE-TEX PERIODONTAL MATERIALW. L. Gore & Associates, Inc.

Official records: FDA product classification for NPK · 21 CFR 872.3930.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026