Barrier, Animal Source, Intraoral
FDA product code NPL · Class II (moderate risk) · 21 CFR 872.3930 · Dental
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.
57510(k) clearances
0PMA approvals
11recalls
Implantimplanted device
Manufacturers
- Collagen Matrix, Inc. 10
- Geistlich Pharma AG 9
- Ed. Geistlich Soehne AG Fuer Chemische Industrie 5
- Cook Biotech, Inc. 3
- Datum Dental, Ltd. 3
- Kensey Nash Corp. 3
- Kerecis Limited 2
- Osseous Technologies of America 1
- Ed. Geistlich Soehne AG Fur Chemische Industrie 1
- Genoss Co., Ltd. 1
- Obi Biologics, Inc. 1
- Biom'Up Sas 1
- Collamatrix Co., Inc. 1
- Matricel GmbH 1
- Tutogen Medical U.S., Inc. 1
- Nibec Co., Ltd. 1
- Osteogenics Biomedical, Inc. (Formerly Obi Biologi 1
- Kensey Nash Corporation Dba Dsm Biomedical 1
- Organogenesis, Inc. 1
- Botiss Biomaterials GmbH 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242817 | Jason membraneNPL · Traditional | Botiss Biomaterials GmbH | 12/12/2025SE |
| K250512 | Augmented Gingival MatrixNPL · Traditional | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 12/05/2025SE |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®NPL · Traditional | Geistlich Pharma AG | 11/25/2025SE |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…NPL · Traditional | Geistlich Pharma AG | 08/14/2025SE |
| K250833 | SwissMembrane X; SwissMembrane X SocketNPL · Special | Geistlich Pharma AG | 04/15/2025SE |
| K233203 | Soft Tissue Augmentation Resorbable MatrixNPL · Traditional | Collagen Matrix, Inc. | 05/01/2024SE |
| K231513 | Oral MatrixNPL · Traditional | Beijing Biosis Healing Biolog Ical Technology… | 02/16/2024SE |
| K231305 | Endoform Dental MembraneNPL · Traditional | Aroa Biosurgery , Ltd. | 01/23/2024SE |
| K230091 | THE CoverNPL · Traditional | Purgo Biologics, Inc. | 10/06/2023SE |
| K223912 | InterCollagen® GuideNPL · Traditional | Sigmagraft, Inc. | 08/17/2023SE |
| K213904 | Kerecis OralNPL · Traditional | Kerecis | 09/30/2022SE |
| K212509 | OSSIX BreezeNPL · Traditional | Datum Dental, Ltd. | 07/18/2022SE |
| K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…NPL · Traditional | Geistlich Pharma AG | 04/05/2022SE |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® SealNPL · Special | Geistlich Pharma AG | 03/03/2021SE |
| K201241 | Striate+NPL · Traditional | Orthocell, Ltd. | 01/11/2021SE |
| K192612 | Kerecis Gingiva GraftNPL · Traditional | Kerecis Limited | 11/13/2020SE |
| K200623 | OssGuideNPL · Traditional | Sk Bioland Co., Ltd. | 10/02/2020SE |
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…NPL · Special | Geistlich Pharma AG | 08/29/2019SE |
| K173562 | Straumann Jason MembraneNPL · Traditional | Institut Straumann AG | 07/09/2018SE |
| K171050 | Geistlich Fibro-GideNPL · Traditional | Geistlich Pharma AG | 11/09/2017SE |
| K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedNPL · Traditional | Geistlich Pharma AG | 10/30/2017SE |
| K161762 | DynaMatrix/Dynamatrix PlusNPL · Special | Cook Biotech Incorporated | 01/13/2017SE |
| K160281 | Ossix PlusNPL · Traditional | Datum Dental, Ltd. | 08/04/2016SE |
| K153549 | Ossix VolumaxNPL · Traditional | Datum Dental, Ltd. | 08/04/2016SE |
| K160474 | DSM Biomedical Porcine Pericardium Dental MembraneNPL · Traditional | Kensey Nash Corporation Dba Dsm Biomedical | 06/07/2016SE |
| K141177 | Vitala Porcine Derived Collagen MembraneNPL · Traditional | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | 09/15/2015SE |
| K142496 | Collagen Dental Membrane - Conformable IIBPNPL · Traditional | Collagen Matrix, Inc. | 11/24/2014SE |
| K141909 | Collagen Dental Membrane - Conformable PPNPL · Traditional | Collagen Matrix, Inc. | 11/05/2014SE |
| K133507 | GuidossNPL · Traditional | Nibec Co., Ltd. | 11/05/2014SE |
| K140518 | Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterNPL · Traditional | Geistlich Pharma AG | 07/18/2014SE |
| K123697 | Matricel Dental Barrier MembraneNPL · Traditional | Matricel GmbH | 02/24/2014SE |
| K121310 | Mesothelium Dental MembraneNPL · Traditional | Kensey Nash Corporation | 07/11/2013SE |
| K100695 | Colladental BarrierNPL · Traditional | Collamatrix, Inc. | 01/03/2013SE |
| K103087 | Covamax Resorbable Collagen MembraneNPL · Traditional | Biom'Up Sas | 08/26/2011SE |
| K110600 | Collagen Dental Mambrane - Porcine Type I CollagenNPL · Traditional | Collagen Matrix, Inc. | 07/29/2011SE |
| K101453 | Vitala Natural Resorbable Collagen MembraneNPL · Traditional | Obi Biologics, Inc. | 07/21/2011SE |
| K102307 | Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsNPL · Traditional | Genoss Co., Ltd. | 05/04/2011SE |
| K102531 | MucograftNPL · Traditional | Ed. Geistlich Soehne AG Fur Chemische Industrie | 11/17/2010SE |
| K100156 | Collagen Dental Membrane VNPL · Traditional | Collagen Matrix, Inc. | 08/11/2010SE |
| K091192 | Kensey Nash P1076 Collagen Dental Membrane, Model 20655-XXNPL · Traditional | Kensey Nash Corp. | 11/02/2009SE |
| K090919 | Kensey Nash Fibrillar Collagen Dental MembraneNPL · Traditional | Kensey Nash Corp. | 10/02/2009SE |
| K090216 | Collagen Dental Membrane IVNPL · Traditional | Collagen Matrix, Inc. | 09/18/2009SE |
| K082058 | DynamatrixNPL · Traditional | Cook Biotech, Inc. | 10/02/2008SE |
| K073685 | Ota Collagen BiomaterialNPL · Traditional | Osseous Technologies of America | 08/29/2008SE |
| K073711 | Mucograft Collagen MatrixNPL · Traditional | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 05/30/2008SE |
| K073097 | Tutodent Dental MembraneNPL · Traditional | Tutogen Medical U.S., Inc. | 05/12/2008SE |
| K071555 | Fortagen Oral MembraneNPL · Traditional | Organogenesis, Inc. | 08/30/2007SE |
| K062846 | Collagen Dental Membrane IIINPL · Special | Collagen Matrix, Inc. | 10/13/2006SE |
| K062881 | Collagen Dental Menbrane - Conformable IINPL · Special | Collagen Matrix, Inc. | 10/11/2006SE |
| K061244 | MucograftNPL · Traditional | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 06/06/2006SE |
| K053260 | Ossix -PlusNPL · Traditional | Colbar Lifescience , Ltd. | 02/22/2006SE |
| K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneNPL · Traditional | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 08/09/2005SE |
| K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone RegenerationNPL · Traditional | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 11/15/2004SE |
| K012423 | MucograftNPL · Traditional | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 01/24/2003SE |
| K010952 | Surgisis Guided Tissue Regeneration MatrixNPL · Traditional | Cook Biotech, Inc. | 06/10/2002SE |
| K011695 | Collagen Dental MembraneNPL · Traditional | Collagen Matrix, Inc. | 08/07/2001SE |
| K003339 | Collagen Periodontal MembraneNPL · Traditional | Collagen Matrix, Inc. | 01/08/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0912-2020 Class II | GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product…The products may have been packaged with an incorrect Instructions for Use. | Collagen Matrix Inc | 11/05/2019Terminated |
| Z-0911-2020 Class II | GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product…The products may have been packaged with an incorrect Instructions for Use. | Collagen Matrix Inc | 11/05/2019Terminated |
| Z-0910-2020 Class II | GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product…The products may have been packaged with an incorrect Instructions for Use. | Collagen Matrix Inc | 11/05/2019Terminated |
| Z-0909-2020 Class II | GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage:…The products may have been packaged with an incorrect Instructions for Use. | Collagen Matrix Inc | 11/05/2019Terminated |
| Z-0908-2020 Class II | GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage:…The products may have been packaged with an incorrect Instructions for Use. | Collagen Matrix Inc | 11/05/2019Terminated |
| Z-0907-2020 Class II | GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage:…The products may have been packaged with an incorrect Instructions for Use. | Collagen Matrix Inc | 11/05/2019Terminated |
| Z-1389-2019 Class II | Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 -…Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem… | Collagen Matrix, Inc. | 03/19/2019Terminated |
| Z-1110-2017 Class II | RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.Lack of sterility assurance | Biom'up | 12/02/2016Terminated |
| Z-1623-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine…Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the… | Kensey Nash Corp | 02/28/2012Terminated |
| Z-1622-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine…Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the… | Kensey Nash Corp | 02/28/2012Terminated |
| Z-1621-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine…Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the… | Kensey Nash Corp | 02/28/2012Terminated |