Barrier, Animal Source, Intraoral
Dental · 21 CFR 872.3930
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.
Recent MDR events
191 adverse event reports on file
- OSSEOGUARD FLEX RESORBABLE COLLAGEN MEMBRANEJul 14, 2026InjuryCollagen Matrix, Inc.2249852-2026-00011
- OSSIX BONEJul 10, 2026InjuryDatum Dental Ltd.3027602316-2026-00027
- OSSIX BONEJul 10, 2026InjuryDatum Dental Ltd.3027602316-2026-00029
- OSSIX BONEJul 10, 2026InjuryDatum Dental Ltd.3027602316-2026-00030
- OSSIX BONEJul 10, 2026InjuryDatum Dental Ltd.3027602316-2026-00031
- OSSIX BONEJul 10, 2026InjuryDatum Dental Ltd.3027602316-2026-00028
- GIBSON HEALTHCARE MEMBRANE 3-4May 22, 2026InjuryCollagen Matrix, Inc.2249852-2026-00010
- BIOGIDE PERIOMay 4, 2026InjuryGeistlich Pharma AgMW5187561
- MEM-LOK RESORBABLE COLLAGEN MEMBRANEMar 3, 2026InjuryCollagen Matrix, Inc.2249852-2026-00009
- MEM-LOK RESORBABLE COLLAGEN MEMBRANEMar 3, 2026InjuryCollagen Matrix, Inc.2249852-2026-00008
Event type breakdown
Recalls
11 recall events for this product code
- Biom'upTerminatedJan 27, 2017
RENOVIX Guided Healing Collagen Membrane
Lack of sterility assurance
Z-1110-2017 · View FDA record ↗ - Kensey Nash CorpTerminatedMay 17, 2012
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,
Z-1621-2012 · View FDA record ↗ - Kensey Nash CorpTerminatedMay 17, 2012
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,
Z-1622-2012 · View FDA record ↗ - Kensey Nash CorpTerminatedMay 17, 2012
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue.
Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,
Z-1623-2012 · View FDA record ↗ - Collagen Matrix IncTerminatedUnknown
GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material f
The products may have been packaged with an incorrect Instructions for Use.
Z-0907-2020 · View FDA record ↗ - Collagen Matrix IncTerminatedUnknown
GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material f
The products may have been packaged with an incorrect Instructions for Use.
Z-0908-2020 · View FDA record ↗ - Collagen Matrix IncTerminatedUnknown
GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material f
The products may have been packaged with an incorrect Instructions for Use.
Z-0909-2020 · View FDA record ↗ - Collagen Matrix IncTerminatedUnknown
GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable mat
The products may have been packaged with an incorrect Instructions for Use.
Z-0910-2020 · View FDA record ↗ - Collagen Matrix IncTerminatedUnknown
GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable mater
The products may have been packaged with an incorrect Instructions for Use.
Z-0911-2020 · View FDA record ↗ - Collagen Matrix IncTerminatedUnknown
GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable mater
The products may have been packaged with an incorrect Instructions for Use.
Z-0912-2020 · View FDA record ↗
Registered firms
142 firms currently registered for this product code
Purgo Biologics Inc.
Seongnam-si Gyeonggi, KR
Isomedix Operations Inc.
CHESTER, NY, US
Prismatik Dentalcraft, Inc.
Irvine, CA, US
Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)
Bridgewater, NJ, US
Dentsply Ih Bv
Sevenum Limburg, NL
Cook Incorporated
ELLETTSVILLE, IN, US
Spfm, L.p.
San Antonio, TX, US
Isomedix Operations Inc.
WHIPPANY, NJ, US
Sigmagraft, Inc.
Fullerton, CA, US
Steritech
Dandenong Victoria, AU
Collagen Matrix, Inc
Allendale, NJ, US
Neoss Ab
Goteborg Vastra Gotaland, SE
Sterigenics Belgium Fleurus Sa
Fleurus Hainaut, BE
Hansamed Limited Dba Citagenix
Mississauga Ontario, CA
Collagen Matrix, Inc.
Oakland, NJ, US
Sweden & Martina Inc
Naperville, IL, US
Dentsply Sirona Inc
York, PA, US
Rose Gmbh Fuer Medizintechnik
Trier Rhineland-Palatinate, DE
Mediplast Israel Ltd
Yavne Tel Aviv, IL
Geistlich Pharma Ag
WOLHUSEN Luzern, CH
Armm, Inc.
HUNTINGTON BEACH, CA, US
510(k) clearances
57 clearances for this product code
- Botiss Biomaterials GmbHDec 12, 2025
K242817 · Jason membrane
- Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.Dec 5, 2025
K250512 · Augmented Gingival Matrix
- Geistlich Pharma AGNov 25, 2025
K252253 · Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
- Geistlich Pharma AGAug 14, 2025
K251062 · Geistlich 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 Pack
- Geistlich Pharma AGApr 15, 2025
K250833 · SwissMembrane X; SwissMembrane X Socket
- Collagen Matrix, Inc.May 1, 2024
K233203 · Soft Tissue Augmentation Resorbable Matrix
- Beijing Biosis Healing Biolog Ical Technology Co., Ltd.Feb 16, 2024
K231513 · Oral Matrix
- Aroa Biosurgery , Ltd.Jan 23, 2024
K231305 · Endoform Dental Membrane