Barrier, Animal Source, Intraoral
Regulation 872.3930
3510(k)s in 12 months (57 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in NPL
| Company | 510(k)s | Recalls |
|---|---|---|
| Collagen Matrix, Inc. | 10 | 7 |
| Geistlich Pharma AG | 9 | 0 |
| Kensey Nash Corp. | 3 | 3 |
| Ed. Geistlich Soehne AG Fuer Chemische Industrie | 5 | 0 |
| Cook Biotech Incorporated | 3 | 0 |
| Datum Dental, Ltd. | 3 | 0 |
| Biom'Up Sas | 1 | 1 |
| Kerecis | 2 | 0 |
| Aroa Biosurgery , Ltd. | 1 | 0 |
| Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 2025 | K242817 | Jason membrane Botiss Biomaterials GmbH, DE | NPL |
| Dec 5, 2025 | K250512 | Augmented Gingival Matrix Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd., CN | NPL |
| Nov 25, 2025 | K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® Geistlich Pharma AG, CH | NPL |
| Aug 14, 2025 | K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio- Geistlich Pharma AG, CH | NPL |
| Apr 15, 2025 | K250833 | SwissMembrane X; SwissMembrane X Socket Geistlich Pharma AG, CH | NPL |
| May 1, 2024 | K233203 | Soft Tissue Augmentation Resorbable Matrix Collagen Matrix, Inc. | NPL |
| Feb 16, 2024 | K231513 | Oral Matrix Beijing Biosis Healing Biolog Ical Technology Co., Ltd., CN | NPL |
| Jan 23, 2024 | K231305 | Endoform Dental Membrane Aroa Biosurgery , Ltd., NZ | NPL |
| Oct 6, 2023 | K230091 | THE Cover Purgo Biologics, Inc., KR | NPL |
| Aug 17, 2023 | K223912 | InterCollagen® Guide Sigmagraft, Inc. | NPL |
| Sep 30, 2022 | K213904 | Kerecis Oral Kerecis, IS | NPL |
| Jul 18, 2022 | K212509 | OSSIX Breeze Datum Dental, Ltd., IL | NPL |
| Apr 5, 2022 | K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-K Geistlich Pharma AG, CH | NPL |
| Mar 3, 2021 | K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal Geistlich Pharma AG, CH | NPL |
| Jan 11, 2021 | K201241 | Striate+ Orthocell, Ltd., AU | NPL |
| Nov 13, 2020 | K192612 | Kerecis Gingiva Graft Kerecis Limited, IS | NPL |
| Oct 2, 2020 | K200623 | OssGuide Sk Bioland Co., Ltd., KR | NPL |
| Aug 29, 2019 | K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-K Geistlich Pharma AG, CH | NPL |
| Jul 9, 2018 | K173562 | Straumann Jason Membrane Institut Straumann AG, CH | NPL |
| Nov 9, 2017 | K171050 | Geistlich Fibro-Gide Geistlich Pharma AG, CH | NPL |
| Oct 30, 2017 | K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed Geistlich Pharma AG, CH | NPL |
| Jan 13, 2017 | K161762 | DynaMatrix/Dynamatrix Plus Cook Biotech Incorporated | NPL |
| Aug 4, 2016 | K160281 | OSSIX PLUS Datum Dental, Ltd., IL | NPL |
| Aug 4, 2016 | K153549 | OSSIX VOLUMAX Datum Dental, Ltd., IL | NPL |
| Jun 7, 2016 | K160474 | DSM Biomedical Porcine Pericardium Dental Membrane Kensey Nash Corporation Dba Dsm Biomedical | NPL |
| Sep 15, 2015 | K141177 | VITALA PORCINE DERIVED COLLAGEN MEMBRANE Osteogenics Biomedical, Inc. (Formerly Obi Biologi | NPL |
| Nov 24, 2014 | K142496 | Collagen Dental Membrane - Conformable IIBP Collagen Matrix, Inc. | NPL |
| Nov 5, 2014 | K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP Collagen Matrix, Inc. | NPL |
| Nov 5, 2014 | K133507 | GUIDOSS Nibec Co., Ltd. | NPL |
| Jul 18, 2014 | K140518 | GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER Geistlich Pharma AG | NPL |
| Feb 24, 2014 | K123697 | MATRICEL DENTAL BARRIER MEMBRANE Matricel GmbH, DE | NPL |
| Jul 11, 2013 | K121310 | MESOTHELIUM DENTAL MEMBRANE Kensey Nash Corporation | NPL |
| Jan 3, 2013 | K100695 | COLLADENTAL BARRIER Collamatrix, Inc., TW | NPL |
| Aug 26, 2011 | K103087 | COVAMAX RESORBABLE COLLAGEN MEMBRANE Biom'Up Sas, FR | NPL |
| Jul 29, 2011 | K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN Collagen Matrix, Inc. | NPL |
| Jul 21, 2011 | K101453 | VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE Obi Biologics, Inc. | NPL |
| May 4, 2011 | K102307 | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS Genoss Co., Ltd. | NPL |
| Nov 17, 2010 | K102531 | MUCOGRAFT Ed. Geistlich Soehne AG Fur Chemische Industrie | NPL |
| Aug 11, 2010 | K100156 | COLLAGEN DENTAL MEMBRANE V Collagen Matrix, Inc. | NPL |
| Nov 2, 2009 | K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX Kensey Nash Corp. | NPL |
| Oct 2, 2009 | K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE Kensey Nash Corp. | NPL |
| Sep 18, 2009 | K090216 | COLLAGEN DENTAL MEMBRANE IV Collagen Matrix, Inc. | NPL |
| Oct 2, 2008 | K082058 | DYNAMATRIX Cook Biotech, Inc. | NPL |
| Aug 29, 2008 | K073685 | OTA COLLAGEN BIOMATERIAL Osseous Technologies of America | NPL |
| May 30, 2008 | K073711 | MUCOGRAFT COLLAGEN MATRIX Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPL |
| May 12, 2008 | K073097 | TUTODENT DENTAL MEMBRANE Tutogen Medical U.S., Inc. | NPL |
| Aug 30, 2007 | K071555 | FORTAGEN ORAL MEMBRANE Organogenesis, Inc. | NPL |
| Oct 13, 2006 | K062846 | COLLAGEN DENTAL MEMBRANE III Collagen Matrix, Inc. | NPL |
| Oct 11, 2006 | K062881 | COLLAGEN DENTAL MENBRANE - CONFORMABLE II Collagen Matrix, Inc. | NPL |
| Jun 6, 2006 | K061244 | MUCOGRAFT Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPL |
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