Dental Device Guide
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Prosthetic devices · 21 CFR 872 Subpart D

Intraoral Animal Source Barrier

An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.

FDA codeNPLClass221 CFR872.3930Pathway510(k)ImplantCategoryBone grafts & membranes
Companies listing it
4424 makers
Brands and models
98
510(k) clearances
5814 in five years
FDA name
Barrier, Animal Source, Intraoral
2001: 22002: 12003: 12004: 12005: 12006: 42007: 12008: 42009: 32010: 22011: 42013: 22014: 52015: 12016: 32017: 32018: 12019: 12020: 22021: 22022: 32023: 22024: 32025: 52026: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list NPL

44 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakerStraumann Membrane Max2122026
Dentsply Sirona, Inc.United StatesMakerOssix Agile · Ossix Breeze · OSSIX Plus · OSSIX VOLUMAX1482026
Geistlich Pharma AGSwitzerlandMakerGeistlich Bio-Gide® · Geistlich Bio-Gide® Compressed · Geistlich Bio-Gide® Forte · Geistlich Bio-Gide® Perio · +3302025
GENOSS Co., Ltd.South KoreaMakerGCM1020 · GCM1515 · GCM1520 · GCM2030 · +6232025
PURGO BIOLOGICS Inc.South KoreaMakerTHE Cover52024
SigmaGraft, Inc.United StatesMakerInterCollagen Guide32023
Collagen Matrix, Inc.United StatesMakerMatrixDerm CAP Regenerative Collagen Dental Membrane · MatrixDerm EXT Regenerative Collagen Dental Membrane · MatrixDerm Regenerative Collagen Dental Membrane · Matrixflex · +2202024
HYUNDAI BIOLAND Co., Ltd.South KoreaMakerOradapt · OsseoSeal · OssGuide · OsteoFlex · +312026
Aroa Biosurgery LtdNew ZealandMakerAroa Dental Membrane · Endoform Dental Membrane12024
botiss biomaterials GmbHGermanyMakerJason membrane · Straumann Jason membrane12025
Beijing Biosis Healing Biological Technology Co., LtdChinaMakerOral Matrix12024
Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.ChinaMakerNeocirrus Augmented Gingival Matrix12025
Osteogenics Biomedical, Inc.United StatesMakerCytoplast RTM Collagen Membrane · Symbios Collagen Membrane · Vitala52021
NIBEC Co LtdSouth KoreaMakerGuidOss · Instradent Membrane · RegenoGide42015
Cook Biotech IncorporatedUnited StatesMakerDynaMatrix · DynaMatrix Plus · DynaMatrix Plus Extracellular Membrane32017
Dsm BiomedicalUnited StatesMakerDSM Biomedical Porcine Pericardium Dental Membrane · Meso Dental Membrane12020
Matricel GmbHGermanyMakercreos xenoprotect · Kontour Matrix · Zmatrix12014
Orthocell LimitedAustraliaMakerperFORM · Striate+12021
STERIS CorporationUnited StatesMaker———
Millstone Medical Outsourcing LLCUnited StatesMaker———
RTI Surgical, Inc. (dba RTI Biologics, Inc.)United StatesMakerCopiOs® Pericardium Membrane · Tutodent® membrane——
biotrics bioimplants AGGermanyMakerJason membrane · Straumann Jason membrane——
AbbVie, Inc.United StatesMakerNovoMatrix™ Reconstructive Tissue Matrix——
Armm, Inc.United StatesMaker———
Prismatik Dentalcraft, Inc.United StatesContract manufacturer—562026
Young Innovations IncUnited StatesContract manufacturerAmpliDerm · AMPLIFI Long Term Membrane · OraMEM® Plus Resorbable Collagen Membrane · Renovix · +1232025
Park Dental Research CorpUnited StatesContract manufacturerStarDerm · StarMem82026
Neoss ABSwedenForeign exporterNeoGen Collagen Firm · NeoGen Collagen Flex102022
Unicare Biomedical, Inc.United StatesManufacturerCollaFlex92015
Bausch & Lomb IncorporatedUnited StatesManufacturer—31994
Ritter Implants GmbH and Co. KGUnited StatesManufacturerOral Matrix22019
Sotera Health LLCUnited StatesContract manufacturerOTA Collagen Biomaterials——
Sweden & Martina INCUnited StatesListerCOLLAGEN DENTAL MEMBRANE · NEOMEM ECM · NEOMEM FLEX PLUS · OSSIX PLUS · +1——
BBF Sterilisationsservice GmbHGermanyContract manufacturerCopiOs Paricardium Membrane——
HANSAMED LIMITED dba CITAGENIXCanadaForeign exporterNeomem · Neomem FlexPlus · The Cover——
Greenpia Technology Inc.South KoreaContract sterilizerOssGuide——
Mediplast Israel Ltd.IsraelContract sterilizerOSSIX Breeze · OSSIX® PLUS · OSSIX® VOLUMAX——
Hudson Scientific LLCUnited StatesRepacker / relabelerOSSIX PLUS · OSSIX VOLUMAX——
Rose GmbH fuer MedizintechnikGermanyContract sterilizerJason membrane · Jason® membrane / Straumann® Jason® membrane · Straumann Jason membrane——
HA2 Medizintechnik GmbHGermanyContract sterilizerCreos xenoprotect, Kontour Matrix, Zmatrix——
SteritechAustraliaContract sterilizerperFORM, MODEL perf1520, perf2030, perf3040 · Striate+, MODEL OCG-152, OCG-203, OCG-304, OCG-405——
Dental Implant Technologies, Inc.United StatesListerOradapt——
Bausch Health US LLCUnited StatesLister———
Cook Inc.United StatesContract sterilizer———

510(k) clearances

Decided510(k)DeviceApplicant
29 Oct 2026K262415OSSIX PlusDatum Dental, Ltd.
12 Dec 2025K242817Jason membranebotiss biomaterials GmbH
5 Dec 2025K250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
25 Nov 2025K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG
14 Aug 2025K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackGeistlich Pharma AG
15 Apr 2025K250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AG
1 May 2024K233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc.
16 Feb 2024K231513Oral MatrixBeijing Biosis Healing Biological Technology Co., Ltd
23 Jan 2024K231305Endoform Dental MembraneAroa Biosurgery Ltd
6 Oct 2023K230091THE CoverPURGO BIOLOGICS Inc.
17 Aug 2023K223912InterCollagen® GuideSigmaGraft, Inc.
30 Sep 2022K213904Kerecis OralKerecis
18 Jul 2022K212509OSSIX BreezeDatum Dental, Ltd.
5 Apr 2022K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi PackGeistlich Pharma AG
3 Mar 2021K210280Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG
11 Jan 2021K201241Striate+™Orthocell Limited
13 Nov 2020K192612Kerecis Gingiva GraftKerecis
2 Oct 2020K200623OssGuideSk Bioland Co., Ltd.
29 Aug 2019K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft SealGeistlich Pharma AG
9 Jul 2018K173562Straumann Jason MembraneInstitut Straumann AG
9 Nov 2017K171050Geistlich Fibro-GideGeistlich Pharma AG
30 Oct 2017K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG
13 Jan 2017K161762DynaMatrix/Dynamatrix PlusCook Biotech Incorporated
4 Aug 2016K160281OSSIX PLUSDatum Dental, Ltd.
4 Aug 2016K153549OSSIX VOLUMAXDatum Dental, Ltd.
7 Jun 2016K160474DSM Biomedical Porcine Pericardium Dental MembraneKensey Nash Corporation Dba Dsm Biomedical
15 Sep 2015K141177VITALA PORCINE DERIVED COLLAGEN MEMBRANEOsteogenics Biomedical, Inc. (Formerly Obi Biologi
24 Nov 2014K142496Collagen Dental Membrane - Conformable IIBPCollagen Matrix, Inc.
5 Nov 2014K141909COLLAGEN DENTAL MEMBRANE - CONFORMABLE PPCollagen Matrix, Inc.
5 Nov 2014K133507GUIDOSSNIBEC Co Ltd
18 Jul 2014K140518GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETERGeistlich Pharma AG
24 Feb 2014K123697MATRICEL DENTAL BARRIER MEMBRANEMatricel GmbH
11 Jul 2013K121310MESOTHELIUM DENTAL MEMBRANEKensey Nash Corporation
3 Jan 2013K100695COLLADENTAL BARRIERCollamatrix, Inc.
26 Aug 2011K103087COVAMAX RESORBABLE COLLAGEN MEMBRANEBiom'Up Sas
29 Jul 2011K110600COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGENCollagen Matrix, Inc.
21 Jul 2011K101453VITALA NATURAL RESORBABLE COLLAGEN MEMBRANEObi Biologics, Inc.
4 May 2011K102307GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELSGENOSS Co., Ltd.
17 Nov 2010K102531MUCOGRAFTEd. Geistlich Soehne AG Fur Chemische Industrie
11 Aug 2010K100156COLLAGEN DENTAL MEMBRANE VCollagen Matrix, Inc.
2 Nov 2009K091192KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XXKensey Nash Corporation
2 Oct 2009K090919KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANEKensey Nash Corporation
18 Sep 2009K090216COLLAGEN DENTAL MEMBRANE IVCollagen Matrix, Inc.
2 Oct 2008K082058DYNAMATRIXCook Biotech Incorporated
29 Aug 2008K073685OTA COLLAGEN BIOMATERIALOsseous Technologies of America
30 May 2008K073711MUCOGRAFT COLLAGEN MATRIXEd. Geistlich Soehne AG Fuer Chemische Industrie
12 May 2008K073097TUTODENT DENTAL MEMBRANETutogen Medical U.S., Inc.
30 Aug 2007K071555FORTAGEN ORAL MEMBRANEOrganogenesis, Inc.
13 Oct 2006K062846COLLAGEN DENTAL MEMBRANE IIICollagen Matrix, Inc.
11 Oct 2006K062881COLLAGEN DENTAL MENBRANE - CONFORMABLE IICollagen Matrix, Inc.
6 Jun 2006K061244MUCOGRAFTEd. Geistlich Soehne AG Fuer Chemische Industrie
22 Feb 2006K053260OSSIX -PLUSColbar Lifescience , Ltd.
9 Aug 2005K050446BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONEEd. Geistlich Soehne AG Fuer Chemische Industrie
15 Nov 2004K042197BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATIONEd. Geistlich Soehne AG Fuer Chemische Industrie
24 Jan 2003K012423MUCOGRAFTEd. Geistlich Soehne AG Fuer Chemische Industrie
10 Jun 2002K010952SURGISIS GUIDED TISSUE REGENERATION MATRIXCook Biotech Incorporated
7 Aug 2001K011695COLLAGEN DENTAL MEMBRANECollagen Matrix, Inc.
8 Jan 2001K003339COLLAGEN PERIODONTAL MEMBRANECollagen Matrix, Inc.

Official records: FDA product classification for NPL · 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